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How Have Advanced Drug Modalities Impacted Bioanalysis?
Blog

How Have Advanced Drug Modalities Impacted Bioanalysis?

What Are Drug-Drug Interactions With Respect To Medicines?
Science in 60

What Are Drug-Drug Interactions With Respect To Medicines?

Neoantigens Revive Vaccine Opportunities in Immuno-Oncology
Blog

Neoantigens Revive Vaccine Opportunities in Immuno-Oncology

Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation
Scientific Poster

Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation

Comparison of the Pharmacokinetics of Four Different Dose- Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study
Scientific Poster

Comparison of the Pharmacokinetics of Four Different Dose- Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study

Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys
Scientific Poster

Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys

Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation
Scientific Poster

Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation

DESIGN OF TOTAL ANTI-VEGF ASSAY PROVIDES SIMPLE DATA INTERPRETATION OF ANTI-VEGF THERAPEUTIC STUDY
Scientific Poster

DESIGN OF TOTAL ANTI-VEGF ASSAY PROVIDES SIMPLE DATA INTERPRETATION OF ANTI-VEGF THERAPEUTIC STUDY

Development of a 10 color flow cytometric assay to assess binding of a monoclonal antibody (VB421) against IGF 1R in Peripheral Blood Mononuclear Cells (PBMCs) from patients with Thyroid Eye Disease
Scientific Poster

Development of a 10 color flow cytometric assay to assess binding of a monoclonal antibody (VB421) against IGF 1R in Peripheral Blood Mononuclear Cells (PBMCs) from patients with Thyroid Eye Disease

Determination of Mifepristone in Human Plasma by Automated On-Line SPE Combined with MS/MS
Scientific Poster

Determination of Mifepristone in Human Plasma by Automated On-Line SPE Combined with MS/MS

Embryo-Fetal Developmental Toxicokinetic Study of CBX129801, a Bio-active C-peptide for Potential Replacement Therapy in Type 1 Diabetic Nephropathy, in Rats and Rabbits After Subcutaneous Injections
Scientific Poster

Embryo-Fetal Developmental Toxicokinetic Study of CBX129801, a Bio-active C-peptide for Potential Replacement Therapy in Type 1 Diabetic Nephropathy, in Rats and Rabbits After Subcutaneous Injections

Phase 1 Pharmacokinetic (PK) Assessment of ATI-1123, a Novel Human Serum Albumin-Stabilized Nanoparticle Docetaxel Liposomal Formulation, in Patients with Advanced Solid Malignancies
Scientific Poster

Phase 1 Pharmacokinetic (PK) Assessment of ATI-1123, a Novel Human Serum Albumin-Stabilized Nanoparticle Docetaxel Liposomal Formulation, in Patients with Advanced Solid Malignancies

Toxicokinetics and Immunogenicity of CBX129801, a Pegylated C-Peptide Drug for Type 1 Diabetes Replacement Therapy, in Sprague Dawley Rats
Scientific Poster

Toxicokinetics and Immunogenicity of CBX129801, a Pegylated C-Peptide Drug for Type 1 Diabetes Replacement Therapy, in Sprague Dawley Rats

Toxicokinetics of ETI-385 and its Components ETI-382 and ETI-383, a Serotonin 5-HT1A Receptor Agonist for Treatment of Nausea and Vomiting, Following Subcutaneous Injection of ETI-385 to CD-1 Mice and Beagle Dogs
Scientific Poster

Toxicokinetics of ETI-385 and its Components ETI-382 and ETI-383, a Serotonin 5-HT1A Receptor Agonist for Treatment of Nausea and Vomiting, Following Subcutaneous Injection of ETI-385 to CD-1 Mice and Beagle Dogs

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Neuropathy, in Rats and Monkeys After Subcutaneous Injections
Scientific Poster

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Neuropathy, in Rats and Monkeys After Subcutaneous Injections

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, Following Subcutaneous Injection of CBX129801 in Monkeys in a 9-Month Study with a 7-Week Recovery Period
Scientific Poster

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, Following Subcutaneous Injection of CBX129801 in Monkeys in a 9-Month Study with a 7-Week Recovery Period

Pharmacokinetics of AC220 and its Active Metabolite AC886, a FLT-3 Inhibitor, Following Sequential Oral Dose Escalation to Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Scientific Poster

Pharmacokinetics of AC220 and its Active Metabolite AC886, a FLT-3 Inhibitor, Following Sequential Oral Dose Escalation to Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Effect of Food on the Pharmacokinetics of Ulifloxacin, a Fluoroquinolone for Bacterial Gastroenteritis Treatment, in Healthy Subjects After Oral Dosing of the Prodrug Prulifloxacin
Scientific Poster

Effect of Food on the Pharmacokinetics of Ulifloxacin, a Fluoroquinolone for Bacterial Gastroenteritis Treatment, in Healthy Subjects After Oral Dosing of the Prodrug Prulifloxacin

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, Following Subcutaneous Injection of CBX129801 in Monkeys in a 9-Month Study with a 7-Week Recovery Period
Scientific Poster

Toxicokinetics of CBX129801, a Bio-active C-Peptide for Potential Replacement Therapy in Type 1 Diabetic Peripheral Neuropathy, Following Subcutaneous Injection of CBX129801 in Monkeys in a 9-Month Study with a 7-Week Recovery Period

Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918, an Encapsulated Liposomal Formulation, and DOXIL® in Female Rats
Scientific Poster

Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918, an Encapsulated Liposomal Formulation, and DOXIL® in Female Rats

Pharmacokinetics of Subcutaneously-administered CBX129801, A Long-acting Synthetic C-Peptide in Patients with Type 1 Diabetes Mellitus
Scientific Poster

Pharmacokinetics of Subcutaneously-administered CBX129801, A Long-acting Synthetic C-Peptide in Patients with Type 1 Diabetes Mellitus

Pharmacokinetic Bioequivalence of ATI-0918 and DOXIL®/CAELYX® in Patients with Ovarian Cancer
Scientific Poster

Pharmacokinetic Bioequivalence of ATI-0918 and DOXIL®/CAELYX® in Patients with Ovarian Cancer

Use of Cold Compounds and High Resolution Mass Spectrometry to Quickly Characterize Drug Uptake in Cryopreserved Human Hepatocytes
Scientific Poster

Use of Cold Compounds and High Resolution Mass Spectrometry to Quickly Characterize Drug Uptake in Cryopreserved Human Hepatocytes

Validated Multi-site GLP-compliant Analysis of Solithromycin (SOLI) in Monkey Plasma Samples Following Filtration to Remove Potentially Active Anthrax Spores
Scientific Poster

Validated Multi-site GLP-compliant Analysis of Solithromycin (SOLI) in Monkey Plasma Samples Following Filtration to Remove Potentially Active Anthrax Spores

Anti‑drug Antibody Sample Testing and Reporting Harmonization
Paper

Anti‑drug Antibody Sample Testing and Reporting Harmonization

Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis
Webinar

Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis

Lynn Kamen and Michelle Miller Talk Bioanalysis: Past, Present, and Future
Podcast

Lynn Kamen and Michelle Miller Talk Bioanalysis: Past, Present, and Future

Multiplexed Cytokine Analysis in Drug Development
Blog

Multiplexed Cytokine Analysis in Drug Development

Potency Assays For ATMPs — Conception, Development, Validation, Matrixed Approaches And Assay Lifecycle
Webinar

Potency Assays For ATMPs — Conception, Development, Validation, Matrixed Approaches And Assay Lifecycle

Bioanalytical Strategies for Oncolytic Virus Therapeutics
Webinar

Bioanalytical Strategies for Oncolytic Virus Therapeutics

What Are We Measuring In A Pharmacokinetic Assay?
Science in 60

What Are We Measuring In A Pharmacokinetic Assay?

Innovations in Microsampling Technologies to Advance Clinical Trial Design
Webinar

Innovations in Microsampling Technologies to Advance Clinical Trial Design

Determining Immunogenicity for CAR-T cell Therapies
Blog

Determining Immunogenicity for CAR-T cell Therapies

Overcoming Bioanalytical Hurdles In The Pharma And Life Sciences Sector
Article

Overcoming Bioanalytical Hurdles In The Pharma And Life Sciences Sector

BIOANALYTICAL DMPK Services
Brochure

BIOANALYTICAL DMPK Services

Non-Proprietary Assay List
Brochure

Non-Proprietary Assay List

Sample Collection & Logistics
Brochure

Sample Collection & Logistics

Collection Kit Supplies
Brochure

Collection Kit Supplies

in Bioanalysis, DMPK, and Pharmacokinetic Analysis
Brochure

in Bioanalysis, DMPK, and Pharmacokinetic Analysis

The Importance Of GMP Certification In Drug Development
Blog

The Importance Of GMP Certification In Drug Development

Platform Usage to Support Advanced Drug Modalities
Webinar

Platform Usage to Support Advanced Drug Modalities

Is ISR Needed For Biomarker Assays?
Blog

Is ISR Needed For Biomarker Assays?

Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation
Scientific Poster

Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation

Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation
Scientific Poster

Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation

Comparison of the Pharmacokinetics of Four Different Dose-Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study
Scientific Poster

Comparison of the Pharmacokinetics of Four Different Dose-Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study

Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys
Scientific Poster

Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys

A Quantitative Method for Determining Hyaluronan Content in Plasma by LC/MS/MS and Plasma HA as a PharmacodynamicMarker for PEGylated-Hyaluronidase PH20 (PEGPH20) in a Phase 1b Trial for Pancreatic Ductal Adenocarcinoma
Scientific Poster

A Quantitative Method for Determining Hyaluronan Content in Plasma by LC/MS/MS and Plasma HA as a PharmacodynamicMarker for PEGylated-Hyaluronidase PH20 (PEGPH20) in a Phase 1b Trial for Pancreatic Ductal Adenocarcinoma

Pharmacokinetic Bioequivalence of ATI-0918 and DOXIL®/CAELYX® in Patients with Ovarian Cancer
Scientific Poster

Pharmacokinetic Bioequivalence of ATI-0918 and DOXIL®/CAELYX® in Patients with Ovarian Cancer

Validated Multi-site GLP-compliant Analysis of Solithromycin (SOLI) in Monkey Plasma Samples Following Filtration to Remove Potentially Active Anthrax Spores
Scientific Poster

Validated Multi-site GLP-compliant Analysis of Solithromycin (SOLI) in Monkey Plasma Samples Following Filtration to Remove Potentially Active Anthrax Spores

Pharmacokinetics of Subcutaneously-administered CBX129801, A Long-acting Synthetic C-peptide in Patients with Type 1 Diabetes Mellitus
Scientific Poster

Pharmacokinetics of Subcutaneously-administered CBX129801, A Long-acting Synthetic C-peptide in Patients with Type 1 Diabetes Mellitus

Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918, an Encapsulated Liposomal Formulation, and DOXIL® in Female Rats
Scientific Poster

Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918, an Encapsulated Liposomal Formulation, and DOXIL® in Female Rats

Genetic Screening and Big Data’s Influence on Drug Production and Biomarker Identification
Blog

Genetic Screening and Big Data’s Influence on Drug Production and Biomarker Identification

What is Simoa and how does it work?
Science in 60

What is Simoa and how does it work?

How does Droplet Digital PCR work?
Science in 60

How does Droplet Digital PCR work?

What Challenge Does Pre-Existing Immunogenicity Present for Gene Therapy?
Science in 60

What Challenge Does Pre-Existing Immunogenicity Present for Gene Therapy?

How Are ELISpot Assays Used For Immunogenicity Testing?
Science in 60

How Are ELISpot Assays Used For Immunogenicity Testing?

What Is A Biomarker?
Science in 60

What Is A Biomarker?

Why Automate?
Science in 60

Why Automate?

What Capabilities Does The Durham Lab Expansion Offer?
Science in 60

What Capabilities Does The Durham Lab Expansion Offer?

Strategies To Overcome Bioanalytical Challenges
Blog

Strategies To Overcome Bioanalytical Challenges

Are We Closer to Using the Word “Cures” More Often?
Blog

Are We Closer to Using the Word “Cures” More Often?

Comparison of Titer and Signal to Noise (S/N) for Determination of Anti‑drug Antibody Magnitude Using Clinical Data from an Industry Consortium
Paper

Comparison of Titer and Signal to Noise (S/N) for Determination of Anti‑drug Antibody Magnitude Using Clinical Data from an Industry Consortium

ADCC and CDC Assay: Validation and Optimization
Blog

ADCC and CDC Assay: Validation and Optimization

ADA Assessment For Cell Therapies
Webinar

ADA Assessment For Cell Therapies

Origins of CRISPR: How it Came to Be
Blog

Origins of CRISPR: How it Came to Be

Strategies for Overcoming Drug Interference in Immunogenicity Assessment
Webinar

Strategies for Overcoming Drug Interference in Immunogenicity Assessment

Plaque Reduction Neutralization Tests (PRNT) and the Development of New Antiviral Drugs
Blog

Plaque Reduction Neutralization Tests (PRNT) and the Development of New Antiviral Drugs

What Parameters Are Acquired from a PK Study?
Blog

What Parameters Are Acquired from a PK Study?

The Use of Cell-Based Assays for Translational Medicine Studies
Blog

The Use of Cell-Based Assays for Translational Medicine Studies

[EPISODE 20] Dr. David Johnson Talks Frosted Flakes, Small Molecules, and Pharmacokinetics!
Podcast

[EPISODE 20] Dr. David Johnson Talks Frosted Flakes, Small Molecules, and Pharmacokinetics!

Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
Paper

Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?

The Broad Array of Vaccine Options for COVID-19
Blog

The Broad Array of Vaccine Options for COVID-19

[EPISODE 19] Tricia Sterling Talks Rare Diseases, Trust, and Advocacy
Podcast

[EPISODE 19] Tricia Sterling Talks Rare Diseases, Trust, and Advocacy

Total Bioanalytical Support for Antibody−Drug Conjugates (ADCs)
Webinar

Total Bioanalytical Support for Antibody−Drug Conjugates (ADCs)

[Episode 18] Dr. Dave Williams Talks Flow Cytometers, Harmony, and KC BBQ!
Podcast

[Episode 18] Dr. Dave Williams Talks Flow Cytometers, Harmony, and KC BBQ!

PK Assessment for Advanced Modalities (Cell & Gene Therapies)
Webinar

PK Assessment for Advanced Modalities (Cell & Gene Therapies)

[Episode 17] Dr. Kevin Bateman talks innovation, dried blood spots, and the LCS model!
Podcast

[Episode 17] Dr. Kevin Bateman talks innovation, dried blood spots, and the LCS model!

Assessing Cellular Immunogenicity via ELISpot
Webinar

Assessing Cellular Immunogenicity via ELISpot

[Episode 16] Angela Luttick talks Australia, Research and Growth! 
Podcast

[Episode 16] Angela Luttick talks Australia, Research and Growth! 

[Episode 15] Neil Spooner Talks Bioanalysis, Microsampling and Homemade Jam!
Podcast

[Episode 15] Neil Spooner Talks Bioanalysis, Microsampling and Homemade Jam!

Validation of qPCR Assays for Gene Therapy
Blog

Validation of qPCR Assays for Gene Therapy

[Episode 14] President & CEO Jim Datin Talks Company Culture, Core Values, and Global Growth!
Podcast

[Episode 14] President & CEO Jim Datin Talks Company Culture, Core Values, and Global Growth!

Bioanalytical Opportunities for Diverse Backgrounds
Youtube

Bioanalytical Opportunities for Diverse Backgrounds

The Importance of Soft Skills for Scientists
Youtube

The Importance of Soft Skills for Scientists

Evolving the Use of Bioanalytical Platforms
Youtube

Evolving the Use of Bioanalytical Platforms

Investing in Innovative Bioanalytical Technology
Youtube

Investing in Innovative Bioanalytical Technology

Changing Trends & the Impact on New Technologies
Youtube

Changing Trends & the Impact on New Technologies

How We Identify and Train Quality Scientific Talent
Youtube

How We Identify and Train Quality Scientific Talent

The BioAgilytix Way
Youtube

The BioAgilytix Way

Utilizing Multiparameter Flow Cytometry in Clinical Trials
Webinar

Utilizing Multiparameter Flow Cytometry in Clinical Trials

Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge
Webinar

Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge

BioAgilytix Adds Extensive Capabilities with the Acquisition of MicroConstants and 360biolabs®️
Blog

BioAgilytix Adds Extensive Capabilities with the Acquisition of MicroConstants and 360biolabs®️

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements
Blog

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

Molecular Methods for Gene Therapies (GMP)
Webinar

Molecular Methods for Gene Therapies (GMP)

Large Molecule Pharmacokinetic Assays for New Modalities
Webinar

Large Molecule Pharmacokinetic Assays for New Modalities

[EPISODE 13] Charles Sabine: Huntington’s Disease, Gene Therapy, and Hope
Podcast

[EPISODE 13] Charles Sabine: Huntington’s Disease, Gene Therapy, and Hope

Update on CAR T-Cell Therapies for the Treatment of Cancer
Blog

Update on CAR T-Cell Therapies for the Treatment of Cancer

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies
Blog

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Cell-Based NAb Assays: What We Need to Know
Blog

Cell-Based NAb Assays: What We Need to Know

[EPISODE 12] Dr. Jennifer Zemo talks mentorship, kinase proteins and customer service!
Podcast

[EPISODE 12] Dr. Jennifer Zemo talks mentorship, kinase proteins and customer service!

Translational Medicine in Drug Development
Webinar

Translational Medicine in Drug Development

[EPISODE 11] Dr. Afshin Safavi Talks About Creating BioAgilytix, Hot Yoga and Rap Music!
Podcast

[EPISODE 11] Dr. Afshin Safavi Talks About Creating BioAgilytix, Hot Yoga and Rap Music!

Bioanalytical Strategies for Biomarker Implementation in Clinical Trials
Webinar

Bioanalytical Strategies for Biomarker Implementation in Clinical Trials

[EPISODE 10] Jeff Sutherland Discusses Dogs: Canine Nutrition and Oncology Advances
Podcast

[EPISODE 10] Jeff Sutherland Discusses Dogs: Canine Nutrition and Oncology Advances

[EPISODE 9] Dr. Jolly Mazumdar and Tim Chendrimada Talks Dreaming Big, Coffee Beans and Self Amplifying RNA!
Podcast

[EPISODE 9] Dr. Jolly Mazumdar and Tim Chendrimada Talks Dreaming Big, Coffee Beans and Self Amplifying RNA!

Gyrolab®: Case Studies in Assay Development and Validation
Webinar

Gyrolab®: Case Studies in Assay Development and Validation

[EPISODE 8] Dr. John Smeraglia Talks Globe Trotting, Italian Food, and Magnetic Sector Mass Spectrometers!
Podcast

[EPISODE 8] Dr. John Smeraglia Talks Globe Trotting, Italian Food, and Magnetic Sector Mass Spectrometers!

[EPISODE 7] Angela Stoyanovitch Talks Detroit Pride, Legal Drugs, and the Google of CROs!
Podcast

[EPISODE 7] Angela Stoyanovitch Talks Detroit Pride, Legal Drugs, and the Google of CROs!

Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market
Blog

Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market

BioAgilytix Team Q&A: Meet Chris Carlin
Blog

BioAgilytix Team Q&A: Meet Chris Carlin

ELISpot method development and validation for gene therapies: building on 2019 WRIB recommendations, practical case studies
Webinar

ELISpot method development and validation for gene therapies: building on 2019 WRIB recommendations, practical case studies

BioAgilytix Team Q&A: Meet Reema Davis
Blog

BioAgilytix Team Q&A: Meet Reema Davis

BioAgilytix Team Q&A: Meet Nikhil Soni
Blog

BioAgilytix Team Q&A: Meet Nikhil Soni

[EPISODE 6] Dr. Laura Sepp-Lorenzino Talks Gene Editing, Mentorships, and Making Big Moves!
Podcast

[EPISODE 6] Dr. Laura Sepp-Lorenzino Talks Gene Editing, Mentorships, and Making Big Moves!

Full-Service Bioanalysis of an Immuno-oncology Program
Webinar

Full-Service Bioanalysis of an Immuno-oncology Program

CMC Requirements for Cell and Gene Therapy for IND Applications
Blog

CMC Requirements for Cell and Gene Therapy for IND Applications

Taking Risks and Setting Precedent in Bioanalytical Assays for Cell & Gene Therapies
Podcast

Taking Risks and Setting Precedent in Bioanalytical Assays for Cell & Gene Therapies

FDA RACE for Children Act: What You Should Know
Blog

FDA RACE for Children Act: What You Should Know

The Benefits of Outsourcing R&D Processes to CROs
Blog

The Benefits of Outsourcing R&D Processes to CROs

[EPISODE 5] Dr. Tina Morris Talks Photography, Bioanalytics, and Leadership!
Podcast

[EPISODE 5] Dr. Tina Morris Talks Photography, Bioanalytics, and Leadership!

Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology
Blog

Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology

The Benefits of Hiring the Right CRO
Blog

The Benefits of Hiring the Right CRO

Bioanalytical Testing for Gene Therapy Webinar
Webinar

Bioanalytical Testing for Gene Therapy Webinar

[EPISODE 4] Mike Mortimer Talks Brexit, Biking and Business!
Podcast

[EPISODE 4] Mike Mortimer Talks Brexit, Biking and Business!

[EPISODE 3] Dr. Binodh DeSilva Talks Kitchen Focus Group, Therapeutics and Missing the Trails!
Podcast

[EPISODE 3] Dr. Binodh DeSilva Talks Kitchen Focus Group, Therapeutics and Missing the Trails!

Immediate Hypersensitivity Reactions Against Biologicals
Webinar

Immediate Hypersensitivity Reactions Against Biologicals

The Importance of Cytokine Detection and Analysis
Blog

The Importance of Cytokine Detection and Analysis

[EPISODE 2] Dr. Marianne Fjording Talks Biomarkers, CROs, and Tomatoes!
Podcast

[EPISODE 2] Dr. Marianne Fjording Talks Biomarkers, CROs, and Tomatoes!

[EPISODE 1] Dr. Jim McNally Talks Gene Therapy, Superheroes and Celery!
Podcast

[EPISODE 1] Dr. Jim McNally Talks Gene Therapy, Superheroes and Celery!

Difference Between Biobetters and Biosimilars
Blog

Difference Between Biobetters and Biosimilars

The Impact of Brexit on European Biotech and Biopharma
Blog

The Impact of Brexit on European Biotech and Biopharma

What to Expect at AAPS 2020 PharmSci 360
Blog

What to Expect at AAPS 2020 PharmSci 360

Utilizing Bradford Assay for Protein Concentration Calculation
Blog

Utilizing Bradford Assay for Protein Concentration Calculation

A Beginner’s Guide to Luciferase Assays
Blog

A Beginner’s Guide to Luciferase Assays

Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
Webinar

Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials

The Difference Between Pharmacokinetics and Pharmacodynamics
Blog

The Difference Between Pharmacokinetics and Pharmacodynamics

How to Apply Fit-for-Purpose Biomarker Assay Validation to Your COU
Webinar

How to Apply Fit-for-Purpose Biomarker Assay Validation to Your COU

NIH to Back CRISPR-Based Rapid COVID-19 Testing
Blog

NIH to Back CRISPR-Based Rapid COVID-19 Testing

Managing Sensitivity in Neutralizing Antibody Assays: When Wide Dynamic Range Makes Yes Mean No and No Mean Yes
Webinar

Managing Sensitivity in Neutralizing Antibody Assays: When Wide Dynamic Range Makes Yes Mean No and No Mean Yes

Webinar Sneak Peek: ELISpot Method Development and Validation for Gene Therapies
Blog

Webinar Sneak Peek: ELISpot Method Development and Validation for Gene Therapies

BioAgilytix’s Boston Team Q&A: Meet Benjamin Lamothe, Clinical Research Scientist
Blog

BioAgilytix’s Boston Team Q&A: Meet Benjamin Lamothe, Clinical Research Scientist

Platform Focus: Flow Cytometry
Brochure

Platform Focus: Flow Cytometry

CLIA, COLA & CAP: What’s the Difference?
Blog

CLIA, COLA & CAP: What’s the Difference?

Making the Move: A Look into the Career Transition from Pharma/Biotech to CRO
Blog

Making the Move: A Look into the Career Transition from Pharma/Biotech to CRO

Analytical Assays Determine Biosimilar Product Quality
Article

Analytical Assays Determine Biosimilar Product Quality

ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends
Webinar

ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends

BioAgilytix Diagnostics
Brochure

BioAgilytix Diagnostics

Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
Blog

Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials

Behind the Science Perspectives with Dr. Jim McNally, BioAgilytix’s Chief Scientific Officer
Blog

Behind the Science Perspectives with Dr. Jim McNally, BioAgilytix’s Chief Scientific Officer

What’s Happening at the 14th WRIB Virtual Meeting?
Blog

What’s Happening at the 14th WRIB Virtual Meeting?

Behind the Science with Dr. Frank Horling, BioAgilytix’s New General Manager, Europe
Blog

Behind the Science with Dr. Frank Horling, BioAgilytix’s New General Manager, Europe

Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb
Blog

Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb

Science On-Demand! : 4th WRIB 2020 | Visit Our Virtual Booth & Watch On-Demand Scientific Presentations from Our Experts!
Videos-old

Science On-Demand! : 4th WRIB 2020 | Visit Our Virtual Booth & Watch On-Demand Scientific Presentations from Our Experts!

The Power of Being NYCE
Blog

The Power of Being NYCE

Scientific Focus: GMP Support for Biotherapeutics
Brochure

Scientific Focus: GMP Support for Biotherapeutics

Bioanalytical Assays for Vaccines
Brochure

Bioanalytical Assays for Vaccines

Meso Scale Discovery® (MSD) V-PLEX Human Biomarker 40-Plex Kit – Validated Panels
Brochure

Meso Scale Discovery® (MSD) V-PLEX Human Biomarker 40-Plex Kit – Validated Panels

New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis
Blog

New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis

COVID-19: Testing for the “Cytokine Release Syndrome, CRS”
Blog

COVID-19: Testing for the “Cytokine Release Syndrome, CRS”

Turning Around a Troubled Study: A Rescue Project Success Story
Blog

Turning Around a Troubled Study: A Rescue Project Success Story

On-Demand Webinar: Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-Viral Antibody
Webinar

On-Demand Webinar: Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-Viral Antibody

Webinar Sneak Peek: Accelerating Testing of Therapeutics to Neutralize Viral Infections
Blog

Webinar Sneak Peek: Accelerating Testing of Therapeutics to Neutralize Viral Infections

Women in STEM: Discussing Technology with BioAgilytix’s Whitney Gonzales this #WomensHistoryMonth
Blog

Women in STEM: Discussing Technology with BioAgilytix’s Whitney Gonzales this #WomensHistoryMonth

Women in STEM: Discussing Science with BioAgilytix’s Dr. Jenn Zemo this #WomensHistoryMonth
Blog

Women in STEM: Discussing Science with BioAgilytix’s Dr. Jenn Zemo this #WomensHistoryMonth

CLIA Requirements for Gene and Cell Therapy Programs
Blog

CLIA Requirements for Gene and Cell Therapy Programs

What to Consider When Assessing CRO Laboratories
Blog

What to Consider When Assessing CRO Laboratories

Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2
Blog

Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2

Questions on Immunogenicity Testing for Biosimilars Answered: Part 1
Blog

Questions on Immunogenicity Testing for Biosimilars Answered: Part 1

Vector Innovation to Improve Gene Therapy Safety: A Credit to Scientific Tenacity
Blog

Vector Innovation to Improve Gene Therapy Safety: A Credit to Scientific Tenacity

Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays
Blog

Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays

“Gene Therapy Innovation, Delivered” Infographic on Modified & Novel Vehicles
Infographic

“Gene Therapy Innovation, Delivered” Infographic on Modified & Novel Vehicles

Bioanalysis for Gene Therapies
Brochure

Bioanalysis for Gene Therapies

Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars
Blog

Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices
Blog

Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices

On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars
Webinar

On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

A Dose of Pharma and Biotech News: December 12, 2019
Blog

A Dose of Pharma and Biotech News: December 12, 2019

Bioanalysis for Oncolytic Virus Therapies
Brochure

Bioanalysis for Oncolytic Virus Therapies

Bioanalysis for Cell Therapies
Brochure

Bioanalysis for Cell Therapies

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays
Blog

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Guidance

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

Immunogenicity Assessment of Gene Therapy Compounds
Article

Immunogenicity Assessment of Gene Therapy Compounds

BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor
Blog

BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor

CRISPR-Cas9 Milestones: The First <em>In Vivo</em> Clinical Trial Is Now Underway in Boston
Blog

CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston

Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies
Brochure

Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies

“The History & Future of Gene Therapy” Infographic
Infographic

“The History & Future of Gene Therapy” Infographic

BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix

Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall
Blog

Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall

Your Questions About Exploratory Biomarker Testing Answered
Blog

Your Questions About Exploratory Biomarker Testing Answered

BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III
Blog

BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III

On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?
Webinar

On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?

BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe
Blog

BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?
Blog

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

Gene Therapy Trends: Conditional Approval of Zynteglo Brings <em>Ex Vivo</em> Gene Therapy Into Focus
Blog

Gene Therapy Trends: Conditional Approval of Zynteglo Brings Ex Vivo Gene Therapy Into Focus

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
Blog

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
Blog

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Immunogenicity Assessment Using the Biacore™ T200 SPR System
Blog

Immunogenicity Assessment Using the Biacore™ T200 SPR System

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?
Blog

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Blog

To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results

Why Biology Matters: The Key to Successful Biomarker Validation
Blog

Why Biology Matters: The Key to Successful Biomarker Validation

BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix

Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered
Blog

Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered

Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019
Paper

Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization
Case Study

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization

A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals
Blog

A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals

On-Demand Webinar: Principles of Immunogenicity Assessment Using Biacore™ T200 SPR System
Webinar

On-Demand Webinar: Principles of Immunogenicity Assessment Using Biacore™ T200 SPR System

Key Takeaways from the 13th Annual WRIB, 2019
Blog

Key Takeaways from the 13th Annual WRIB, 2019

Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts
Webinar

Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today
Blog

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Immunogenicity Assessment of Gene Therapy Compounds
Blog

Immunogenicity Assessment of Gene Therapy Compounds

What Drives BioAgilytix’s #TeamBehindtheScience?
Blog

What Drives BioAgilytix’s #TeamBehindtheScience?

BioAgilytix Team Q&A: Meet Charlie Walker, Associate Director of Finance at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Charlie Walker, Associate Director of Finance at BioAgilytix

The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment
Blog

The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment

Podcast: Enabling Tomorrow’s Breakthroughs Today
Videos-old

Podcast: Enabling Tomorrow’s Breakthroughs Today

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
Blog

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress
Blog

Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis
Blog

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis

Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy
Case Study

Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy

Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype
Blog

Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype

A Dose of Pharma and Biotech News: February 13, 2019
Blog

A Dose of Pharma and Biotech News: February 13, 2019

BioAgilytix Team Q&A: Meet David Rusnak, Director of Laboratory Systems and Automation at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet David Rusnak, Director of Laboratory Systems and Automation at BioAgilytix

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors
Blog

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

BioAgilytix Team Q&A: Meet Gabi Schewe, Lab Manager at BioAgilytix Europe
Blog

BioAgilytix Team Q&A: Meet Gabi Schewe, Lab Manager at BioAgilytix Europe

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
Guidance

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019

Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used
Blog

Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used

Webinar Recap: Your Questions About Unwanted Drug-Induced Immune Responses
Blog

Webinar Recap: Your Questions About Unwanted Drug-Induced Immune Responses

Have a Slipping Study? Don’t Change Your Assay, Change Your CRO
Blog

Have a Slipping Study? Don’t Change Your Assay, Change Your CRO

Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success
Blog

Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success

CBI and The Prion Alliance at the Broad Institute Collaboration
Blog

CBI and The Prion Alliance at the Broad Institute Collaboration

Webinar Sneak Peek: Clinical Relevance of (Unwanted Drug-Induced) Immune Responses
Blog

Webinar Sneak Peek: Clinical Relevance of (Unwanted Drug-Induced) Immune Responses

Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses
Webinar

Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses

BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester
Blog

BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester

Making an Impact: Molecular Biomarkers Inform the Drug Development Process for Large and Small Molecule Drugs
Blog

Making an Impact: Molecular Biomarkers Inform the Drug Development Process for Large and Small Molecule Drugs

BioAgilytix Team Q&A: Meet Dave Williams, Director, Bioanalytical Operations at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Dave Williams, Director, Bioanalytical Operations at BioAgilytix

A Dose of Pharma and Biotech News: September 19, 2018
Blog

A Dose of Pharma and Biotech News: September 19, 2018

Platform Spotlight: Biacore™ to Detect and Characterize ADAs in Immunogenicity Studies
Blog

Platform Spotlight: Biacore™ to Detect and Characterize ADAs in Immunogenicity Studies

Using Partnerships to Guide New Bioanalytical Technology Investments
Blog

Using Partnerships to Guide New Bioanalytical Technology Investments

The Evolution of Bioanalytical Outsourcing Partnerships
Blog

The Evolution of Bioanalytical Outsourcing Partnerships

Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms
Videos-old

Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms

BioAgilytix Team Q&A: Meet Sarah Rieveschl, Business Development Director at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Sarah Rieveschl, Business Development Director at BioAgilytix

Setting Yourself Up for Success: Advice for Early Career Scientists
Blog

Setting Yourself Up for Success: Advice for Early Career Scientists

The Challenges Associated with Implementing New Bioanalytical Technologies
Blog

The Challenges Associated with Implementing New Bioanalytical Technologies

Business of Bioanalysis: Focusing on the Bioanalytical Data’s End Use
Videos-old

Business of Bioanalysis: Focusing on the Bioanalytical Data’s End Use

Supporting Strong Partnerships with Bioanalysis Sponsor Companies
Videos-old

Supporting Strong Partnerships with Bioanalysis Sponsor Companies

Examining the Demand for New Bioanalytical Technologies as a Contract Research Organization
Blog

Examining the Demand for New Bioanalytical Technologies as a Contract Research Organization

Business of Bioanalysis: Changing Trends & the Impact on New Technologies
Videos-old

Business of Bioanalysis: Changing Trends & the Impact on New Technologies

Attracting and Retaining Scientific Talent in a Complex, Competitive Industry
Blog

Attracting and Retaining Scientific Talent in a Complex, Competitive Industry

Business of Bioanalysis: Reverse Engineering Technology Requirements
Videos-old

Business of Bioanalysis: Reverse Engineering Technology Requirements

BioAgilytix Team Q&A: Meet Beth Heinz, Vice President of Global Business Development at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Beth Heinz, Vice President of Global Business Development at BioAgilytix

Business of Bioanalysis: Forward Looking Vendors as an Ideal Partner
Videos-old

Business of Bioanalysis: Forward Looking Vendors as an Ideal Partner

Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms
Videos-old

Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms

Biologics Market Growth Demands Quality Science that Can Keep Pace
Blog

Biologics Market Growth Demands Quality Science that Can Keep Pace

Business of Bioanalysis: The Spread of Drug Development Throughout the World
Videos-old

Business of Bioanalysis: The Spread of Drug Development Throughout the World

Business of Bioanalysis: The Inherent Risk in Depending on a Single Platform
Videos-old

Business of Bioanalysis: The Inherent Risk in Depending on a Single Platform

Key Takeaways from the 14th Annual PEGS Summit
Blog

Key Takeaways from the 14th Annual PEGS Summit

Proof of Concept to Solution: A Unique Approach to Anti-PEG Antibodies Assessment
Blog

Proof of Concept to Solution: A Unique Approach to Anti-PEG Antibodies Assessment

BioAgilytix Team Q&A: Meet William Hunter, Director of Business Development and Global Key Accounts at BioAgilytix Europe
Blog

BioAgilytix Team Q&A: Meet William Hunter, Director of Business Development and Global Key Accounts at BioAgilytix Europe

Introducing Technology Improvements During a Bioanalysis Study
Videos-old

Introducing Technology Improvements During a Bioanalysis Study

Evaluation of CAR T-Cell Therapy Toxicities by Measurement of Cytokines During Therapy
Blog

Evaluation of CAR T-Cell Therapy Toxicities by Measurement of Cytokines During Therapy

FDA Guidance for Industry: Bioanalytical Method Validation, May 2018
Guidance

FDA Guidance for Industry: Bioanalytical Method Validation, May 2018

BioAgilytix Team Q&A: Meet Florian Sieglitz, Principal Investigator and BPM at BioAgilytix Europe
Blog

BioAgilytix Team Q&A: Meet Florian Sieglitz, Principal Investigator and BPM at BioAgilytix Europe

Key Takeaways from the 12th Workshop on Recent Issues in Bioanalysis (WRIB)
Blog

Key Takeaways from the 12th Workshop on Recent Issues in Bioanalysis (WRIB)

BioAgilytix: Impacting Our Industry, Science, and Patient Health for 10 Years
Blog

BioAgilytix: Impacting Our Industry, Science, and Patient Health for 10 Years

Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment
Blog

Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment

Business of Bioanalysis: Investing in Technology Implementation
Videos-old

Business of Bioanalysis: Investing in Technology Implementation

Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments
Videos-old

Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments

Business of Bioanalysis: Understanding ROI in Platform Selection
Videos-old

Business of Bioanalysis: Understanding ROI in Platform Selection

BioAgilytix Team Q&A: Meet Jon Rush, Project Manager at BioAgilytix
Blog

BioAgilytix Team Q&A: Meet Jon Rush, Project Manager at BioAgilytix

Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars
Article

Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations
Blog

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Business of Bioanalysis: The Challenges of Software Validation
Videos-old

Business of Bioanalysis: The Challenges of Software Validation

Clinical relevance of immunogenicity: an interview with Arno Kromminga
Article

Clinical relevance of immunogenicity: an interview with Arno Kromminga

CAR T-Cell Therapy: Changing the Way Cancer is Treated
Blog

CAR T-Cell Therapy: Changing the Way Cancer is Treated

Platform Spotlight: Extending Capacity for Immune Response Monitoring and Cell Line Characterization with BD FACSLyric™
Blog

Platform Spotlight: Extending Capacity for Immune Response Monitoring and Cell Line Characterization with BD FACSLyric™

Exploratory biomarker testing: to qualify or validate the assay?
Article

Exploratory biomarker testing: to qualify or validate the assay?

A Dose of Pharma and Biotech News: March 7, 2018
Blog

A Dose of Pharma and Biotech News: March 7, 2018

BioAgilytix Team Q&A: Meet Daniel Cohen, Business Development Director, Mid-Atlantic and Asia
Blog

BioAgilytix Team Q&A: Meet Daniel Cohen, Business Development Director, Mid-Atlantic and Asia

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods
Case Study

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays
Blog

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Strategic Bioanalytical Partnerships for the Win-Win-Win
Blog

Strategic Bioanalytical Partnerships for the Win-Win-Win

Preparing and Editing Calibration Curves in Quantitative Ligand Binding Assays: What are the Best Practices?
Blog

Preparing and Editing Calibration Curves in Quantitative Ligand Binding Assays: What are the Best Practices?

BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager
Blog

BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager

Exploratory Biomarker Testing: to Qualify or Validate the Assay?
Blog

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling
Blog

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling

The Scientific Topics that Shaped Our 2017
Blog

The Scientific Topics that Shaped Our 2017

Modern Challenges of Single and Multiplex Biomarker Validation
Blog

Modern Challenges of Single and Multiplex Biomarker Validation

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment
Paper

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

Recommendations for Preparation, Design, and Editing of Calibration Curves
Paper

Recommendations for Preparation, Design, and Editing of Calibration Curves

Immunogenicity Considerations for ADCs: A Focus on Neutralizing Antibody Assays
Article

Immunogenicity Considerations for ADCs: A Focus on Neutralizing Antibody Assays

BioAgilytix Team Q&A: Meet Christine Ford, Corporate Compliance Manager
Blog

BioAgilytix Team Q&A: Meet Christine Ford, Corporate Compliance Manager

BioAgilytix Team Q&A: Meet Jessica Rohrman, Scientist II and Bioanalytical Project Manager
Blog

BioAgilytix Team Q&A: Meet Jessica Rohrman, Scientist II and Bioanalytical Project Manager

BioAgilytix Team Q&A: Meet Angela Daniels, QC Specialist IV
Blog

BioAgilytix Team Q&A: Meet Angela Daniels, QC Specialist IV

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars
Blog

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars

Business of Bioanalysis: Merger and Acquisition Challenges for CROs
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Business of Bioanalysis: Merger and Acquisition Challenges for CROs

Business of Bioanalysis: Creating Additional Value Through M&A
Videos-old

Business of Bioanalysis: Creating Additional Value Through M&A

The Importance of Company Culture in CRO Mergers
Videos-old

The Importance of Company Culture in CRO Mergers

Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities
Videos-old

Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities

Business of Bioanalysis: The Impact of Pharma Mergers on CROs
Videos-old

Business of Bioanalysis: The Impact of Pharma Mergers on CROs

Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’
Webinar

Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies
Blog

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies

Business of Bioanalysis: The Importance of Soft Skills for Scientists
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Business of Bioanalysis: The Importance of Soft Skills for Scientists

Bioanalytical Opportunities for Diverse Backgrounds
Videos-old

Bioanalytical Opportunities for Diverse Backgrounds

Business of Bioanalysis: How we Develop Scientists Through Functional Project Teams
Videos-old

Business of Bioanalysis: How we Develop Scientists Through Functional Project Teams

Business of Bioanalysis: Supporting the Diverse Needs of Our Employees
Videos-old

Business of Bioanalysis: Supporting the Diverse Needs of Our Employees

Why Bioanalytical Technology Strategies Require an Analytical Approach
Blog

Why Bioanalytical Technology Strategies Require an Analytical Approach

Business of Bioanalysis: Our Commitment to Employee Recognition
Videos-old

Business of Bioanalysis: Our Commitment to Employee Recognition

Business of Bioanalysis: How We Identify and Train Quality Scientific Talent
Videos-old

Business of Bioanalysis: How We Identify and Train Quality Scientific Talent

Business of Bioanalysis: When to Bring in New Bioanalytical Technology
Videos-old

Business of Bioanalysis: When to Bring in New Bioanalytical Technology

Business of Bioanalysis: Investing in Innovative Bioanalytical Technology
Videos-old

Business of Bioanalysis: Investing in Innovative Bioanalytical Technology

Outsourcing Bioanalysis: An Opportunity to Enhance Your Large Molecule Development Strategy
Blog

Outsourcing Bioanalysis: An Opportunity to Enhance Your Large Molecule Development Strategy

BioAgilytix: Taking Action to Guide Effective Biosimilar Development
Blog

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

Bioanalysis Zone’s “Ask the Experts” Series on Biosimilars
Article

Bioanalysis Zone’s “Ask the Experts” Series on Biosimilars

Managing Diverse Bioanalytical Talent in an Evolving Industry
Blog

Managing Diverse Bioanalytical Talent in an Evolving Industry

Platform Spotlight: Analyze Immunology Assays on a Nanoliter Scale with Gyros
Blog

Platform Spotlight: Analyze Immunology Assays on a Nanoliter Scale with Gyros

Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling
Paper

Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling

Defining Best Practices for Biosimilar Development
Article

Defining Best Practices for Biosimilar Development

Investing in Emerging Bioanalytical Technologies: A Balancing Act
Blog

Investing in Emerging Bioanalytical Technologies: A Balancing Act

Influencers in the Assessment of Immunogenicity, Part 1: The Basics of Immunology
Blog

Influencers in the Assessment of Immunogenicity, Part 1: The Basics of Immunology

Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently
Blog

Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently

Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity
Webinar

Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity

Right the First Time, for the Right Results: CRO Selection is a Critical First Step
Blog

Right the First Time, for the Right Results: CRO Selection is a Critical First Step

A Dose of Pharma and Biotech News: August 9, 2017
Blog

A Dose of Pharma and Biotech News: August 9, 2017

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP
Blog

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP

Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection
Blog

Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System
Blog

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

Preparing for the Implications of “Brexit” in the Pharmaceutical Industry
Blog

Preparing for the Implications of “Brexit” in the Pharmaceutical Industry

ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis
Blog

ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis

A Dose of Pharma and Biotech News: June 28, 2017
Blog

A Dose of Pharma and Biotech News: June 28, 2017

Supreme Court Decision Creates an Opportunity for Biosimilar Developers
Blog

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis
Videos-old

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis

Leading the Way in Large Molecule Bioanalysis, Our Way
Blog

Leading the Way in Large Molecule Bioanalysis, Our Way

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors
Blog

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors

Outsourcing Clinical Biomarkers: Challenges and Opportunities
Blog

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Considerations to Set ADA Cut Points
Blog

Considerations to Set ADA Cut Points

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit
Blog

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit

The Future of Bioanalytical Outsourcing: What It Means for Our Industry
Blog

The Future of Bioanalytical Outsourcing: What It Means for Our Industry

Cell-Based Assays Keep Biosimilars on Track
Article

Cell-Based Assays Keep Biosimilars on Track

The Challenges of Standardizing Commercial Kits for Biomarker Quantification: Work Planning and Vendor Selection
Blog

The Challenges of Standardizing Commercial Kits for Biomarker Quantification: Work Planning and Vendor Selection

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis
Brochure

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1
Blog

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

Interview with Afshin Safavi (Founder & CSO, BioAgilytix) on biomarker analysis in support of preclinical and clinical studies
Article

Interview with Afshin Safavi (Founder & CSO, BioAgilytix) on biomarker analysis in support of preclinical and clinical studies

Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment
Blog

Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment

Managing unwanted immunogenicity of therapeutic proteins
Paper

Managing unwanted immunogenicity of therapeutic proteins

I Saw the Future and the Future is Biomarkers
Blog

I Saw the Future and the Future is Biomarkers

BioAgilytix: From Solution Provider to Problem Solver
Blog

BioAgilytix: From Solution Provider to Problem Solver

BioAgilytix Scientific Focus: Biomarkers
Brochure

BioAgilytix Scientific Focus: Biomarkers

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses
Blog

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation
Blog

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?
Blog

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers
Blog

Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers

Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Article

Meeting the Rigorous Demands of Biosimilar Pharmacokinetics

2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity
Paper

2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity

Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis
Blog

Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

AAPS Webinar Recording: Bioanalytical Methods in Support of Biosimilar Drug Development
Webinar

AAPS Webinar Recording: Bioanalytical Methods in Support of Biosimilar Drug Development

BioAgilytix Scientific Focus: Cell-Based Assays
Brochure

BioAgilytix Scientific Focus: Cell-Based Assays

What a Year! Looking Back at What’s Driving Us Forward in 2017
Blog

What a Year! Looking Back at What’s Driving Us Forward in 2017

Humoral Immune Response to AAV
Paper

Humoral Immune Response to AAV

Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success
Blog

Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success

CRO Communication: Responsiveness for Better Bioanalytical Results
Blog

CRO Communication: Responsiveness for Better Bioanalytical Results

In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?
Blog

In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other
Blog

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

BioAgilytix Scientific Focus: Immunogenicity
Brochure

BioAgilytix Scientific Focus: Immunogenicity

BioAgilytix Scientific Focus: Pharmacokinetics (PK)
Brochure

BioAgilytix Scientific Focus: Pharmacokinetics (PK)

What You Won’t Learn in School: Advice to Early Career Scientists
Blog

What You Won’t Learn in School: Advice to Early Career Scientists

Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges
Blog

Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges

Biomarker Development: Clearing the Way for Faster Biomarker Innovation
Blog

Biomarker Development: Clearing the Way for Faster Biomarker Innovation

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’
Blog

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

The Importance of Parallelism in Biomarker Assay Development
Blog

The Importance of Parallelism in Biomarker Assay Development

Toxicology and Agatha Christie: An Arresting Pairing
Blog

Toxicology and Agatha Christie: An Arresting Pairing

‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis
Blog

‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies
Blog

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016
Guidance

Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016

EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015
Guidance

EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015

Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015
Guidance

Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015
Guidance

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014
Guidance

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014

What’s Your System for Cell-Based Assay Method Selection?
Blog

What’s Your System for Cell-Based Assay Method Selection?

Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
Paper

Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study

Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study
Paper

Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays
Blog

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory
Blog

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera
Paper

B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead
Blog

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead

How to win client trust as a CRO
Article

How to win client trust as a CRO

Running a successful CRO
Article

Running a successful CRO

How to set up a successful CRO by surrounding yourself with the right team members
Article

How to set up a successful CRO by surrounding yourself with the right team members

Starting a CRO on Personal Credit
Article

Starting a CRO on Personal Credit

Virtual Podium: Biomarkers for Heart Disease in African American Women with Lupus
Videos-old

Virtual Podium: Biomarkers for Heart Disease in African American Women with Lupus

Virtual Podium: Biomarkers and Alzheimer’s Disease
Videos-old

Virtual Podium: Biomarkers and Alzheimer’s Disease

Virtual Podium: Seeking the Biomarkers of Alzheimer’s Disease – On Our Mind
Videos-old

Virtual Podium: Seeking the Biomarkers of Alzheimer’s Disease – On Our Mind

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity
Videos-old

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity

The quintessence of immunogenicity reporting for biotherapeutics
Paper

The quintessence of immunogenicity reporting for biotherapeutics

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein
Paper

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

Virtual Podium: How is Your Assay Performing? Biomarker Validation Best-Practices
Videos-old

Virtual Podium: How is Your Assay Performing? Biomarker Validation Best-Practices

Virtual Podium: An Analytical Approach to Platform Comparison
Videos-old

Virtual Podium: An Analytical Approach to Platform Comparison

Virtual Podium: What’s Your System for Cell-Based Assay Method Selection
Videos-old

Virtual Podium: What’s Your System for Cell-Based Assay Method Selection

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
Paper

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis (Part 3 – LBA and Immunogenicity)
Paper

2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis (Part 3 – LBA and Immunogenicity)

7th GCC Insights: Incurred samples use, solution stability, and more
Paper

7th GCC Insights: Incurred samples use, solution stability, and more

Case Studies: Challenges of Supporting Comparability Work for Biosimilars
Paper

Case Studies: Challenges of Supporting Comparability Work for Biosimilars

7th GCC Insights: incurred samples use; fitfor- Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing
Paper

7th GCC Insights: incurred samples use; fitfor- Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Paper

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Parallelism and Matrix Interference: The Importance of Nomenclature (Part 1)
Article

Parallelism and Matrix Interference: The Importance of Nomenclature (Part 1)

Bioanalytical Buyer’s Guide
eBook

Bioanalytical Buyer’s Guide

Recommendations on incurred sample stability (ISS) by GCC
Paper

Recommendations on incurred sample stability (ISS) by GCC

Growing Clinical Biomarker Assays
Article

Growing Clinical Biomarker Assays

Potential induction of anti-PEG antibodies – PEGylated therapeutics
Paper

Potential induction of anti-PEG antibodies – PEGylated therapeutics

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations
Paper

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Paper

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Paper

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
Paper

Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations
Paper

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway
Paper

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

Webinar: Assay and Kit Lot Considerations for Single and Multiplex Biomarker Analysis
Webinar

Webinar: Assay and Kit Lot Considerations for Single and Multiplex Biomarker Analysis

Development and validation of an alpha fetoprotein immunoassay
Article

Development and validation of an alpha fetoprotein immunoassay

Implementation of a universal analytical method in early-stage development of human antibody therapeutics
Article

Implementation of a universal analytical method in early-stage development of human antibody therapeutics

Validation of a Gyrolab™ assay for quantification of rituximab in human serum
Article

Validation of a Gyrolab™ assay for quantification of rituximab in human serum

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
Paper

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
Article

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS
Paper

2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab
Paper

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Immune responses to AAV vectors: overcoming barriers to successful gene therapy
Paper

Immune responses to AAV vectors: overcoming barriers to successful gene therapy

Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer
Paper

Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
Paper

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
Paper

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013
Guidance

FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013

In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes)
Paper

In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes)

Biosimilars: what clinicians should know
Paper

Biosimilars: what clinicians should know

Setting the stage for biosimilar monoclonal antibodies
Paper

Setting the stage for biosimilar monoclonal antibodies

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012
Guidance

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012

6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity for Endogenous Compounds; Biomarkers; Biosimilars
Paper

6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity for Endogenous Compounds; Biomarkers; Biosimilars

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Paper

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Recommendations on biomarker bioanalytical method validation by GCC
Paper

Recommendations on biomarker bioanalytical method validation by GCC

Virtual Podium: Western Blot Protocol
Videos-old

Virtual Podium: Western Blot Protocol

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Paper

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Immunogenicity assays and comparability studies in biosimilar drugs
Paper

Immunogenicity assays and comparability studies in biosimilar drugs

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines
Paper

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines

Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs by Global CRO Council for Bioanalysis (GCC)
Paper

Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs by Global CRO Council for Bioanalysis (GCC)

6th GCC – “Focus on Ligand-Binding Assays”
Paper

6th GCC – “Focus on Ligand-Binding Assays”

Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies
Article

Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies

Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Paper

Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process
Paper

Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, February 2012
Guidance

FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, February 2012

EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012
Guidance

EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012

Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents
Paper

Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents

Ligand Binding Assays in the 21st Century Laboratory: Automation
Paper

Ligand Binding Assays in the 21st Century Laboratory: Automation

Ligand Binding Assays in the 21st Century Laboratory: Platforms
Paper

Ligand Binding Assays in the 21st Century Laboratory: Platforms

Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis
Paper

Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis

The Determination of Cardiac Toxicity Biomarkers in Rat Serum
Article

The Determination of Cardiac Toxicity Biomarkers in Rat Serum

Evaluation of Multiplex Electrochemiluminescent Immunoassays for Quantitative Determination of Kidney Injury Biomarkers in Rat Urine
Article

Evaluation of Multiplex Electrochemiluminescent Immunoassays for Quantitative Determination of Kidney Injury Biomarkers in Rat Urine

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
Paper

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development

EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010
Guidance

EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010

EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009
Guidance

EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009

EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009
Guidance

EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009

EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007
Guidance

EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007

EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005
Guidance

EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005

EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002
Guidance

EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002

FDA Guideline on validation of bioanalytical methods, May 2001
Guidance

FDA Guideline on validation of bioanalytical methods, May 2001

ICH Q2B Guideline Validation of Analytical Procedures Methodology
Guidance

ICH Q2B Guideline Validation of Analytical Procedures Methodology

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Guidance

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

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USA HQ

2300 Englert Dr

Durham, NC, 27713

919-381-6097

Fax 919-381-6099

San Diego Laboratory

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San Diego, CA 92121

858-652-4600

Fax 858-652-4699

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Queensland, 4102, Australia

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