The BioAgilytix Way of Thinking

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

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

The Use of Cell-Based Assays for Translational Medicine Studies

The Use of Cell-Based Assays for Translational Medicine Studies

ADCC and CDC Assay: Validation and Optimization

ADCC and CDC Assay: Validation and Optimization

ADA Assessment For Cell Therapies

ADA Assessment For Cell Therapies

Origins of CRISPR: How it Came to Be

Origins of CRISPR: How it Came to Be

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

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

Strategies for Overcoming Drug Interference in Immunogenicity Assessment

Strategies for Overcoming Drug Interference in Immunogenicity Assessment

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

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

What Parameters Are Acquired from a PK Study?

What Parameters Are Acquired from a PK Study?

What Capabilities Does the Durham Lab Expansion Offer?

What Capabilities Does the Durham Lab Expansion Offer?

Why Automate?

Why Automate?

What is a biomarker?

What is a biomarker?

How are ELISpot assays used for immunogenicity testing?

How are ELISpot assays used for immunogenicity testing?

How does droplet digital PCR Work?

How does droplet digital PCR Work?

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

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

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

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

The Broad Array of Vaccine Options for COVID-19

The Broad Array of Vaccine Options for COVID-19

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

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

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

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

PK Assessment for Advanced Modalities (Cell & Gene Therapies)

PK Assessment for Advanced Modalities (Cell & Gene Therapies)

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

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

Assessing Cellular Immunogenicity via ELISpot

Assessing Cellular Immunogenicity via ELISpot

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

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

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

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

Validation of qPCR Assays for Gene Therapy

Validation of qPCR Assays for Gene Therapy

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

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

Bioanalytical Opportunities for Diverse Backgrounds

Bioanalytical Opportunities for Diverse Backgrounds

The Importance of Soft Skills for Scientists

The Importance of Soft Skills for Scientists

Evolving the Use of Bioanalytical Platforms

Evolving the Use of Bioanalytical Platforms

Investing in Innovative Bioanalytical Technology

Investing in Innovative Bioanalytical Technology

Changing Trends & the Impact on New Technologies

Changing Trends & the Impact on New Technologies

How We Identify and Train Quality Scientific Talent

How We Identify and Train Quality Scientific Talent

The BioAgilytix Way

The BioAgilytix Way

Utilizing Multiparameter Flow Cytometry in Clinical Trials

Utilizing Multiparameter Flow Cytometry in Clinical Trials

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

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®️

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

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

Molecular Methods for Gene Therapies (GMP)

Molecular Methods for Gene Therapies (GMP)

Large Molecule Pharmacokinetic Assays for New Modalities

Large Molecule Pharmacokinetic Assays for New Modalities

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

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

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

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

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Cell-Based NAb Assays: What We Need to Know

Cell-Based NAb Assays: What We Need to Know

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

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

Translational Medicine in Drug Development

Translational Medicine in Drug Development

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

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

Bioanalytical Strategies for Biomarker Implementation in Clinical Trials

Bioanalytical Strategies for Biomarker Implementation in Clinical Trials

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

[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!

[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

Gyrolab®: Case Studies in Assay Development and Validation

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

[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!

[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

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

BioAgilytix Team Q&A: Meet Chris Carlin

BioAgilytix Team Q&A: Meet Chris Carlin

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

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

BioAgilytix Team Q&A: Meet Reema Davis

BioAgilytix Team Q&A: Meet Reema Davis

BioAgilytix Team Q&A: Meet Nikhil Soni

BioAgilytix Team Q&A: Meet Nikhil Soni

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

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

Full-Service Bioanalysis of an Immuno-oncology Program

Full-Service Bioanalysis of an Immuno-oncology Program

CMC Requirements for Cell and Gene Therapy for IND Applications

CMC Requirements for Cell and Gene Therapy for IND Applications

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

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

FDA RACE for Children Act: What You Should Know

FDA RACE for Children Act: What You Should Know

The Benefits of Outsourcing R&D Processes to CROs

The Benefits of Outsourcing R&D Processes to CROs

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

[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

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

The Benefits of Hiring the Right CRO

The Benefits of Hiring the Right CRO

Bioanalytical Testing for Gene Therapy Webinar

Bioanalytical Testing for Gene Therapy Webinar

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

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

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

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

Immediate Hypersensitivity Reactions Against Biologicals

Immediate Hypersensitivity Reactions Against Biologicals

The Importance of Cytokine Detection and Analysis

The Importance of Cytokine Detection and Analysis

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

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

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

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

Difference Between Biobetters and Biosimilars

Difference Between Biobetters and Biosimilars

The Impact of Brexit on European Biotech and Biopharma

The Impact of Brexit on European Biotech and Biopharma

What to Expect at AAPS 2020 PharmSci 360

What to Expect at AAPS 2020 PharmSci 360

Utilizing Bradford Assay for Protein Concentration Calculation

Utilizing Bradford Assay for Protein Concentration Calculation

A Beginner’s Guide to Luciferase Assays

A Beginner’s Guide to Luciferase Assays

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

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

The Difference Between Pharmacokinetics and Pharmacodynamics

The Difference Between Pharmacokinetics and Pharmacodynamics

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

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

NIH to Back CRISPR-Based Rapid COVID-19 Testing

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

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

On-Demand Recording: Creating an Effective & Sustainable Employee Testing Strategy: Live Q&A with the Experts!

On-Demand Recording: Creating an Effective & Sustainable Employee Testing Strategy: Live Q&A with the Experts!

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

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

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

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

Platform Focus: Flow Cytometry

Platform Focus: Flow Cytometry

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

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

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

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

Analytical Assays Determine Biosimilar Product Quality

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

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

BioAgilytix Diagnostics

BioAgilytix Diagnostics

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

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

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

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

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

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

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

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

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!

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

The Power of Being NYCE

The Power of Being NYCE

Scientific Focus: GMP Support for Biotherapeutics

Scientific Focus: GMP Support for Biotherapeutics

Bioanalytical Assays for Vaccines

Bioanalytical Assays for Vaccines

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

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

New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis

New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis

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

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

Turning Around a Troubled Study: A Rescue Project Success Story

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

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

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

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

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

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

CLIA Requirements for Gene and Cell Therapy Programs

CLIA Requirements for Gene and Cell Therapy Programs

What to Consider When Assessing CRO Laboratories

What to Consider When Assessing CRO Laboratories

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

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

Questions on Immunogenicity Testing for Biosimilars Answered: Part 1

Questions on Immunogenicity Testing for Biosimilars Answered: Part 1

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

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

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

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

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

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

Bioanalysis for Gene Therapies

Bioanalysis for Gene Therapies

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

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

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

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

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

Bioanalysis for Oncolytic Virus Therapies

Bioanalysis for Oncolytic Virus Therapies

Bioanalysis for Cell Therapies

Bioanalysis for Cell Therapies

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

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

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

Immunogenicity Assessment of Gene Therapy Compounds

Immunogenicity Assessment of Gene Therapy Compounds

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

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

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

Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies

Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies

“The History & Future of Gene Therapy” Infographic

“The History & Future of Gene Therapy” Infographic

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

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

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

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

Your Questions About Exploratory Biomarker Testing Answered

Your Questions About Exploratory Biomarker Testing Answered

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

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

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

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

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

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

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

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

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

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

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

Immunogenicity Assessment Using the Biacore™ T200 SPR System

Immunogenicity Assessment Using the Biacore™ T200 SPR System

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

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

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

Why Biology Matters: The Key to Successful Biomarker Validation

Why Biology Matters: The Key to Successful Biomarker Validation

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

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

Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered

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

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

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

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

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

Key Takeaways from the 13th Annual WRIB, 2019

Key Takeaways from the 13th Annual WRIB, 2019

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

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

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Immunogenicity Assessment of Gene Therapy Compounds

Immunogenicity Assessment of Gene Therapy Compounds

What Drives BioAgilytix’s #TeamBehindtheScience?

What Drives BioAgilytix’s #TeamBehindtheScience?

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

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

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

Podcast: Enabling Tomorrow’s Breakthroughs Today

Podcast: Enabling Tomorrow’s Breakthroughs Today

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success

Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success

CBI and The Prion Alliance at the Broad Institute Collaboration

CBI and The Prion Alliance at the Broad Institute Collaboration

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

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

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

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

BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester

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

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

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

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

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

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

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

Using Partnerships to Guide New Bioanalytical Technology Investments

Using Partnerships to Guide New Bioanalytical Technology Investments

The Evolution of Bioanalytical Outsourcing Partnerships

The Evolution of Bioanalytical Outsourcing Partnerships

Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms

Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms

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

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

Setting Yourself Up for Success: Advice for Early Career Scientists

Setting Yourself Up for Success: Advice for Early Career Scientists

The Challenges Associated with Implementing New Bioanalytical Technologies

The Challenges Associated with Implementing New Bioanalytical Technologies

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

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

Supporting Strong Partnerships with Bioanalysis Sponsor Companies

Supporting Strong Partnerships with Bioanalysis Sponsor Companies

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

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

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

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

Attracting and Retaining Scientific Talent in a Complex, Competitive Industry

Attracting and Retaining Scientific Talent in a Complex, Competitive Industry

Business of Bioanalysis: Reverse Engineering Technology Requirements

Business of Bioanalysis: Reverse Engineering Technology Requirements

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

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

Business of Bioanalysis: Forward Looking Vendors as an Ideal Partner

Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms

Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms

Biologics Market Growth Demands Quality Science that Can Keep Pace

Biologics Market Growth Demands Quality Science that Can Keep Pace

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

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

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

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

Key Takeaways from the 14th Annual PEGS Summit

Key Takeaways from the 14th Annual PEGS Summit

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

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

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

Introducing Technology Improvements During a Bioanalysis Study

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

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

FDA Guidance for Industry: Bioanalytical Method Validation, May 2018

FDA Guidance for Industry: Bioanalytical Method Validation, May 2018

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

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)

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

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

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

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

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

Business of Bioanalysis: Investing in Technology Implementation

Business of Bioanalysis: Investing in Technology Implementation

Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments

Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments

Business of Bioanalysis: Understanding ROI in Platform Selection

Business of Bioanalysis: Understanding ROI in Platform Selection

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

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

Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars

Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars

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

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

Business of Bioanalysis: The Challenges of Software Validation

Business of Bioanalysis: The Challenges of Software Validation

Clinical relevance of immunogenicity: an interview with Arno Kromminga

Clinical relevance of immunogenicity: an interview with Arno Kromminga

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

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™

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

Exploratory biomarker testing: to qualify or validate the assay?

Exploratory biomarker testing: to qualify or validate the assay?

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

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

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

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

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

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

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

Strategic Bioanalytical Partnerships for the Win-Win-Win

Strategic Bioanalytical Partnerships for the Win-Win-Win

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

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

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

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

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

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

The Scientific Topics that Shaped Our 2017

The Scientific Topics that Shaped Our 2017

Modern Challenges of Single and Multiplex Biomarker Validation

Modern Challenges of Single and Multiplex Biomarker Validation

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

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

Recommendations for Preparation, Design, and Editing of Calibration Curves

Recommendations for Preparation, Design, and Editing of Calibration Curves

Immunogenicity Considerations for ADCs: A Focus on Neutralizing Antibody Assays

Immunogenicity Considerations for ADCs: A Focus on Neutralizing Antibody Assays

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

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

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

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

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

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

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

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

Business of Bioanalysis: Merger and Acquisition Challenges for CROs

Business of Bioanalysis: Merger and Acquisition Challenges for CROs

Business of Bioanalysis: Creating Additional Value Through M&A

Business of Bioanalysis: Creating Additional Value Through M&A

The Importance of Company Culture in CRO Mergers

The Importance of Company Culture in CRO Mergers

Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities

Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities

Business of Bioanalysis: The Impact of Pharma Mergers on CROs

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

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies

Business of Bioanalysis: The Importance of Soft Skills for Scientists

Business of Bioanalysis: The Importance of Soft Skills for Scientists

Bioanalytical Opportunities for Diverse Backgrounds

Bioanalytical Opportunities for Diverse Backgrounds

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

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

Business of Bioanalysis: Supporting the Diverse Needs of Our Employees

Business of Bioanalysis: Supporting the Diverse Needs of Our Employees

Why Bioanalytical Technology Strategies Require an Analytical Approach

Why Bioanalytical Technology Strategies Require an Analytical Approach

Business of Bioanalysis: Our Commitment to Employee Recognition

Business of Bioanalysis: Our Commitment to Employee Recognition

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

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

Business of Bioanalysis: When to Bring in New Bioanalytical Technology

Business of Bioanalysis: When to Bring in New Bioanalytical Technology

Business of Bioanalysis: Investing in Innovative Bioanalytical Technology

Business of Bioanalysis: Investing in Innovative Bioanalytical Technology

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

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

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

BioAgilytix: Taking Action to Guide Effective Biosimilar Development

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

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

Managing Diverse Bioanalytical Talent in an Evolving Industry

Managing Diverse Bioanalytical Talent in an Evolving Industry

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

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

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

Defining Best Practices for Biosimilar Development

Investing in Emerging Bioanalytical Technologies: A Balancing Act

Investing in Emerging Bioanalytical Technologies: A Balancing Act

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

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

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 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

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

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

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

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

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

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

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

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

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

ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis

ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis

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

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

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis

Leading the Way in Large Molecule Bioanalysis, Our Way

Leading the Way in Large Molecule Bioanalysis, Our Way

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

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

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Considerations to Set ADA Cut Points

Considerations to Set ADA Cut Points

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

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

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

Cell-Based Assays Keep Biosimilars on Track

Cell-Based Assays Keep Biosimilars on Track

ATCC and BioAgilytix: End-to-End Cell-Based Assay Development Services

ATCC and BioAgilytix: End-to-End Cell-Based Assay Development Services

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

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

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis

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

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

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

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

Managing unwanted immunogenicity of therapeutic proteins

Managing unwanted immunogenicity of therapeutic proteins

I Saw the Future and the Future is Biomarkers

I Saw the Future and the Future is Biomarkers

BioAgilytix: From Solution Provider to Problem Solver

BioAgilytix: From Solution Provider to Problem Solver

BioAgilytix Scientific Focus: Biomarkers

BioAgilytix Scientific Focus: Biomarkers

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Webinar Recording: Considerations for Evaluation of Accuracy, Parallelism and Reagent Lot to Lot Variability in Single and Multiplex Biomarker Ligand-Binding Assays

Webinar Recording: Considerations for Evaluation of Accuracy, Parallelism and Reagent Lot to Lot Variability in Single and Multiplex Biomarker Ligand-Binding Assays

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

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

Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers

Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers

Meeting the Rigorous Demands of Biosimilar Pharmacokinetics

Meeting the Rigorous Demands of Biosimilar Pharmacokinetics

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

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

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

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

BioAgilytix Scientific Focus: Cell-Based Assays

BioAgilytix Scientific Focus: Cell-Based Assays

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

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

Humoral Immune Response to AAV

Humoral Immune Response to AAV

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

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

CRO Communication: Responsiveness for Better Bioanalytical Results

CRO Communication: Responsiveness for Better Bioanalytical Results

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

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

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

BioAgilytix Scientific Focus: Immunogenicity

BioAgilytix Scientific Focus: Immunogenicity

BioAgilytix Scientific Focus: Pharmacokinetics (PK)

BioAgilytix Scientific Focus: Pharmacokinetics (PK)

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

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

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

Biomarker Development: Clearing the Way for Faster Biomarker Innovation

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

The Importance of Parallelism in Biomarker Assay Development

The Importance of Parallelism in Biomarker Assay Development

Toxicology and Agatha Christie: An Arresting Pairing

Toxicology and Agatha Christie: An Arresting Pairing

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

‘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

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 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

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 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 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

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?

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

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

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

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

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

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

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

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

How to win client trust as a CRO

How to win client trust as a CRO

Running a successful CRO

Running a successful CRO

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

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

Starting a CRO on Personal Credit

Starting a CRO on Personal Credit

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

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

Virtual Podium: Biomarkers and Alzheimer’s Disease

Virtual Podium: Biomarkers and Alzheimer’s Disease

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

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

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity

The quintessence of immunogenicity reporting for biotherapeutics

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

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

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

Virtual Podium: An Analytical Approach to Platform Comparison

Virtual Podium: An Analytical Approach to Platform Comparison

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

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)

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)

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

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

Case Studies: Challenges of Supporting Comparability Work for Biosimilars

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

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

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)

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

Bioanalytical Buyer’s Guide

Bioanalytical Buyer’s Guide

Recommendations on incurred sample stability (ISS) by GCC

Recommendations on incurred sample stability (ISS) by GCC

Growing Clinical Biomarker Assays

Growing Clinical Biomarker Assays

Potential induction of anti-PEG antibodies – PEGylated therapeutics

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

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

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)

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

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

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

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

Development and validation of an alpha fetoprotein immunoassay

Development and validation of an alpha fetoprotein immunoassay

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

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

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

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

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

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

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

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

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

Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer

Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer

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

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

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

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

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

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

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

Biosimilars: what clinicians should know

Biosimilars: what clinicians should know

Setting the stage for biosimilar monoclonal antibodies

Setting the stage for biosimilar monoclonal antibodies

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

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

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

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

Recommendations on biomarker bioanalytical method validation by GCC

Virtual Podium: Western Blot Protocol

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)

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

Immunogenicity assays and comparability studies in biosimilar drugs

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

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)

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”

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

Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies

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)

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

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

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

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

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

Ligand Binding Assays in the 21st Century Laboratory: Automation

Ligand Binding Assays in the 21st Century Laboratory: Automation

Ligand Binding Assays in the 21st Century Laboratory: Platforms

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

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

The Determination of Cardiac Toxicity Biomarkers in Rat Serum

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

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

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

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

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

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

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

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

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

FDA Guideline on validation of bioanalytical methods, May 2001

ICH Q2B Guideline Validation of Analytical Procedures Methodology

ICH Q2B Guideline Validation of Analytical Procedures Methodology

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

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USA HQ

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Durham, NC, 27713

919-381-6097

Fax 919-381-6099

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San Diego, CA 92121

858-652-4600

Fax 617-456-0700

Brisbane Laboratory

37 Kent St,Woolloongabba

Queensland, 4102, Australia

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

03 9282 2184

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European HQ

Lademannbogen 10

22339 Hamburg Germany

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

Copyright © 2022 BioAgilytix Labs.

All rights reserved.