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Podcast
[EPISODE 8] Dr. John Smeraglia Talks Globe Trotting, Italian Food, and Magnetic Sector Mass Spectrometers!
Podcast
[EPISODE 7] Angela Stoyanovitch Talks Detroit Pride, Legal Drugs, and the Google of CROs!
Blog
Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market
Blog
BioAgilytix Team Q&A: Meet Chris Carlin
Webinar
ELISpot method development and validation for gene therapies: building on 2019 WRIB recommendations, practical case studies
Blog
BioAgilytix Team Q&A: Meet Reema Davis
Blog
BioAgilytix Team Q&A: Meet Nikhil Soni
Blog
New Opportunities for Women in Science and Technology
Podcast
[EPISODE 6] Dr. Laura Sepp-Lorenzino Talks Gene Editing, Mentorships, and Making Big Moves!
Webinar
Full-Service Bioanalysis of an Immuno-oncology Program
Blog
CMC Requirements for Cell and Gene Therapy for IND Applications
Podcast
Taking Risks and Setting Precedent in Bioanalytical Assays for Cell & Gene Therapies
Blog
FDA RACE for Children Act: What You Should Know
Blog
The Benefits of Outsourcing R&D Processes to CROs
Podcast
[EPISODE 5] Dr. Tina Morris Talks Photography, Bioanalytics, and Leadership!
Blog
Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology
Blog
The Benefits of Hiring the Right CRO
Webinar
Bioanalytical Testing for Gene Therapy Webinar
Podcast
[EPISODE 4] Mike Mortimer Talks Brexit, Biking and Business!
Podcast
[EPISODE 3] Dr. Binodh DeSilva Talks Kitchen Focus Group, Therapeutics and Missing the Trails!
Webinar
Immediate Hypersensitivity Reactions Against Biologicals
Blog
The Importance of Cytokine Detection and Analysis
Podcast
[EPISODE 2] Dr. Marianne Fjording Talks Biomarkers, CROs, and Tomatoes!
Podcast
[EPISODE 1] Dr. Jim McNally Talks Gene Therapy, Superheroes and Celery!
Blog
Difference Between Biobetters and Biosimilars
Blog
The Impact of Brexit on European Biotech and Biopharma
Blog
What to Expect at AAPS 2020 PharmSci 360
Blog
Utilizing Bradford Assay for Protein Concentration Calculation
Blog
A Beginner’s Guide to Luciferase Assays
Webinar
Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
Blog
The Difference Between Pharmacokinetics and Pharmacodynamics
Webinar
How to Apply Fit-for-Purpose Biomarker Assay Validation to Your COU
Blog
NIH to Back CRISPR-Based Rapid COVID-19 Testing
Webinar
Managing Sensitivity in Neutralizing Antibody Assays: When Wide Dynamic Range Makes Yes Mean No and No Mean Yes
Webinar
On-Demand Recording: Creating an Effective & Sustainable Employee Testing Strategy: Live Q&A with the Experts!
Blog
Webinar Sneak Peek: ELISpot Method Development and Validation for Gene Therapies
Blog
BioAgilytix’s Boston Team Q&A: Meet Benjamin Lamothe, Clinical Research Scientist
Datasheet
Platform Focus: Flow Cytometry
Blog
COVID-19 Employee Testing: Where to Begin?
Blog
CLIA, COLA & CAP: What’s the Difference?
Blog
Making the Move: A Look into the Career Transition from Pharma/Biotech to CRO
Article
Analytical Assays Determine Biosimilar Product Quality
Webinar
ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends
Datasheet
BioAgilytix Diagnostics
Blog
Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
Blog
Bruton’s Tyrosine Kinase (BTK) Target Occupancy Assays and COVID-19
Blog
Behind the Science Perspectives with Dr. Jim McNally, BioAgilytix’s Chief Scientific Officer
Blog
What’s Happening at the 14th WRIB Virtual Meeting?
Blog
Behind the Science with Dr. Frank Horling, BioAgilytix’s New General Manager, Europe
Datasheet
COVID-19 Testing for Return-to-Work Surveillance
Blog
Clinical Trials and Returning to Work: COVID-19 Testing, The Path Forward
Blog
Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb
Video
Science On-Demand! : 4th WRIB 2020 | Visit Our Virtual Booth & Watch On-Demand Scientific Presentations from Our Experts!
Blog
The Power of Being NYCE
Datasheet
SARS-CoV-2 Testing: Specific Methods to Detect & Characterize Responses to the Virus Causing COVID-19
Datasheet
Scientific Focus: GMP Support for Biotherapeutics
Datasheet
Bioanalytical Assays for Vaccines
Datasheet
Meso Scale Discovery® (MSD) V-PLEX Human Biomarker 40-Plex Kit – Validated Panels
Blog
New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis
Blog
Science Can’t Be Stopped: Pushing Forward Health Breakthroughs & Hope in Uncertain Times
Blog
COVID-19: Testing for the “Cytokine Release Syndrome, CRS”
Blog
Turning Around a Troubled Study: A Rescue Project Success Story
Webinar
On-Demand Webinar: Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-Viral Antibody
Blog
Webinar Sneak Peek: Accelerating Testing of Therapeutics to Neutralize Viral Infections
Blog
Women in STEM: Discussing Technology with BioAgilytix’s Whitney Gonzales this #WomensHistoryMonth
Blog
Women in STEM: Discussing Science with BioAgilytix’s Dr. Jenn Zemo this #WomensHistoryMonth
Blog
CLIA Requirements for Gene and Cell Therapy Programs
Blog
What to Consider When Assessing CRO Laboratories
Blog
Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2
Blog
Questions on Immunogenicity Testing for Biosimilars Answered: Part 1
Blog
Vector Innovation to Improve Gene Therapy Safety: A Credit to Scientific Tenacity
Blog
Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays
Infographic
“Gene Therapy Innovation, Delivered” Infographic on Modified & Novel Vehicles
Datasheet
Bioanalysis for Gene Therapies
Blog
Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars
Blog
Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices
Webinar
On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars
Blog
A Dose of Pharma and Biotech News: December 12, 2019
Datasheet
Bioanalysis for Oncolytic Virus Therapies
Datasheet
Bioanalysis for Cell Therapies
Blog
Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays
Guidance
Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Article
Immunogenicity Assessment of Gene Therapy Compounds
Blog
BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor
Blog
CRISPR-Cas9 Milestones: The First
In Vivo
Clinical Trial Is Now Underway in Boston
Datasheet
Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies
Infographic
“The History & Future of Gene Therapy” Infographic
Blog
BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix
Blog
Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall
Blog
Your Questions About Exploratory Biomarker Testing Answered
Blog
BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III
Webinar
On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?
Blog
BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe
Blog
Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?
Blog
Gene Therapy Trends: Conditional Approval of Zynteglo Brings
Ex Vivo
Gene Therapy Into Focus
Blog
C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
Blog
Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
Blog
Immunogenicity Assessment Using the Biacore™ T200 SPR System
Blog
510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?
Blog
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Blog
Why Biology Matters: The Key to Successful Biomarker Validation
Blog
BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix
Blog
Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered
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
Case Study
Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization
Blog
A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals
Webinar
On-Demand Webinar: Principles of Immunogenicity Assessment Using Biacore™ T200 SPR System
Blog
Key Takeaways from the 13th Annual WRIB, 2019
Webinar
Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts
Blog
Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today
Blog
Immunogenicity Assessment of Gene Therapy Compounds
Blog
What Drives BioAgilytix’s #TeamBehindtheScience?
Blog
BioAgilytix Team Q&A: Meet Charlie Walker, Associate Director of Finance at BioAgilytix
Blog
The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment
Video
Podcast: Enabling Tomorrow’s Breakthroughs Today
Blog
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
Blog
Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress
Blog
Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis
Case Study
Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy
Blog
Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype
Blog
A Dose of Pharma and Biotech News: February 13, 2019
Blog
BioAgilytix Team Q&A: Meet David Rusnak, Director of Laboratory Systems and Automation at BioAgilytix
Blog
The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors
Blog
BioAgilytix Team Q&A: Meet Gabi Schewe, Lab Manager at BioAgilytix Europe
Guidance
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
Blog
Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used
Blog
Webinar Recap: Your Questions About Unwanted Drug-Induced Immune Responses
Blog
Have a Slipping Study? Don’t Change Your Assay, Change Your CRO
Blog
Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success
Blog
CBI and The Prion Alliance at the Broad Institute Collaboration
Blog
Webinar Sneak Peek: Clinical Relevance of (Unwanted Drug-Induced) Immune Responses
Webinar
Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses
Blog
BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester
Blog
Making an Impact: Molecular Biomarkers Inform the Drug Development Process for Large and Small Molecule Drugs
Blog
BioAgilytix Team Q&A: Meet Dave Williams, Director, Bioanalytical Operations at BioAgilytix
Blog
A Dose of Pharma and Biotech News: September 19, 2018
Blog
Platform Spotlight: Biacore™ to Detect and Characterize ADAs in Immunogenicity Studies
Blog
Using Partnerships to Guide New Bioanalytical Technology Investments
Blog
The Evolution of Bioanalytical Outsourcing Partnerships
Video
Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms
Blog
BioAgilytix Team Q&A: Meet Sarah Rieveschl, Business Development Director at BioAgilytix
Blog
Setting Yourself Up for Success: Advice for Early Career Scientists
Blog
The Challenges Associated with Implementing New Bioanalytical Technologies
Video
Business of Bioanalysis: Focusing on the Bioanalytical Data’s End Use
Video
Supporting Strong Partnerships with Bioanalysis Sponsor Companies
Blog
Examining the Demand for New Bioanalytical Technologies as a Contract Research Organization
Video
Business of Bioanalysis: Changing Trends & the Impact on New Technologies
Blog
Attracting and Retaining Scientific Talent in a Complex, Competitive Industry
Video
Business of Bioanalysis: Reverse Engineering Technology Requirements
Blog
BioAgilytix Team Q&A: Meet Beth Heinz, Vice President of Global Business Development at BioAgilytix
Video
Business of Bioanalysis: Forward Looking Vendors as an Ideal Partner
Video
Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms
Blog
Biologics Market Growth Demands Quality Science that Can Keep Pace
Video
Business of Bioanalysis: The Spread of Drug Development Throughout the World
Video
Business of Bioanalysis: The Inherent Risk in Depending on a Single Platform
Blog
Key Takeaways from the 14th Annual PEGS Summit
Blog
Proof of Concept to Solution: A Unique Approach to Anti-PEG Antibodies Assessment
Blog
BioAgilytix Team Q&A: Meet William Hunter, Director of Business Development and Global Key Accounts at BioAgilytix Europe
Video
Introducing Technology Improvements During a Bioanalysis Study
Blog
Evaluation of CAR T-Cell Therapy Toxicities by Measurement of Cytokines During Therapy
Guidance
FDA Guidance for Industry: Bioanalytical Method Validation, May 2018
Blog
BioAgilytix Team Q&A: Meet Florian Sieglitz, Principal Investigator and BPM at BioAgilytix Europe
Blog
Key Takeaways from the 12th Workshop on Recent Issues in Bioanalysis (WRIB)
Blog
BioAgilytix: Impacting Our Industry, Science, and Patient Health for 10 Years
Blog
Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment
Video
Business of Bioanalysis: Investing in Technology Implementation
Video
Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments
Video
Business of Bioanalysis: Understanding ROI in Platform Selection
Blog
BioAgilytix Team Q&A: Meet Jon Rush, Project Manager at BioAgilytix
Article
Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars
Blog
Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations
Video
Business of Bioanalysis: The Challenges of Software Validation
Article
Clinical relevance of immunogenicity: an interview with Arno Kromminga
Blog
CAR T-Cell Therapy: Changing the Way Cancer is Treated
Blog
Platform Spotlight: Extending Capacity for Immune Response Monitoring and Cell Line Characterization with BD FACSLyric™
Article
Exploratory biomarker testing: to qualify or validate the assay?
Blog
A Dose of Pharma and Biotech News: March 7, 2018
Blog
BioAgilytix Team Q&A: Meet Daniel Cohen, Business Development Director, Mid-Atlantic and Asia
Case Study
Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods
Blog
Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays
Blog
Strategic Bioanalytical Partnerships for the Win-Win-Win
Blog
Preparing and Editing Calibration Curves in Quantitative Ligand Binding Assays: What are the Best Practices?
Blog
BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager
Blog
Exploratory Biomarker Testing: to Qualify or Validate the Assay?
Blog
Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling
Blog
The Scientific Topics that Shaped Our 2017
Blog
Modern Challenges of Single and Multiplex Biomarker Validation
Paper
Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment
Paper
Recommendations for Preparation, Design, and Editing of Calibration Curves
Article
Immunogenicity Considerations for ADCs: A Focus on Neutralizing Antibody Assays
Blog
BioAgilytix Team Q&A: Meet Christine Ford, Corporate Compliance Manager
Blog
BioAgilytix Team Q&A: Meet Jessica Rohrman, Scientist II and Bioanalytical Project Manager
Blog
BioAgilytix Team Q&A: Meet Angela Daniels, QC Specialist IV
Blog
Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars
Video
Business of Bioanalysis: Merger and Acquisition Challenges for CROs
Video
Business of Bioanalysis: Creating Additional Value Through M&A
Video
The Importance of Company Culture in CRO Mergers
Video
Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities
Video
Business of Bioanalysis: The Impact of Pharma Mergers on CROs
Webinar
Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’
Blog
How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies
Video
Business of Bioanalysis: The Importance of Soft Skills for Scientists
Video
Bioanalytical Opportunities for Diverse Backgrounds
Video
Business of Bioanalysis: How we Develop Scientists Through Functional Project Teams
Video
Business of Bioanalysis: Supporting the Diverse Needs of Our Employees
Blog
Why Bioanalytical Technology Strategies Require an Analytical Approach
Video
Business of Bioanalysis: Our Commitment to Employee Recognition
Video
Business of Bioanalysis: How We Identify and Train Quality Scientific Talent
Video
Business of Bioanalysis: When to Bring in New Bioanalytical Technology
Video
Business of Bioanalysis: Investing in Innovative Bioanalytical Technology
Blog
Outsourcing Bioanalysis: An Opportunity to Enhance Your Large Molecule Development Strategy
Blog
BioAgilytix: Taking Action to Guide Effective Biosimilar Development
Article
Bioanalysis Zone’s “Ask the Experts” Series on Biosimilars
Blog
Managing Diverse Bioanalytical Talent in an Evolving Industry
Blog
Platform Spotlight: Analyze Immunology Assays on a Nanoliter Scale with Gyros
Paper
Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling
Article
Defining Best Practices for Biosimilar Development
Blog
Investing in Emerging Bioanalytical Technologies: A Balancing Act
Blog
Influencers in the Assessment of Immunogenicity, Part 1: The Basics of Immunology
Blog
Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently
Webinar
Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity
Blog
Right the First Time, for the Right Results: CRO Selection is a Critical First Step
Blog
A Dose of Pharma and Biotech News: August 9, 2017
Blog
Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP
Blog
Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection
Blog
Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System
Blog
Preparing for the Implications of “Brexit” in the Pharmaceutical Industry
Blog
ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis
Blog
A Dose of Pharma and Biotech News: June 28, 2017
Blog
Supreme Court Decision Creates an Opportunity for Biosimilar Developers
Video
The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis
Blog
Leading the Way in Large Molecule Bioanalysis, Our Way
Blog
The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors
Blog
Outsourcing Clinical Biomarkers: Challenges and Opportunities
Blog
Considerations to Set ADA Cut Points
Blog
The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit
Blog
The Future of Bioanalytical Outsourcing: What It Means for Our Industry
Article
Cell-Based Assays Keep Biosimilars on Track
Datasheet
ATCC and BioAgilytix: End-to-End Cell-Based Assay Development Services
Blog
The Challenges of Standardizing Commercial Kits for Biomarker Quantification: Work Planning and Vendor Selection
Datasheet
BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis
Blog
The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1
Article
Interview with Afshin Safavi (Founder & CSO, BioAgilytix) on biomarker analysis in support of preclinical and clinical studies
Blog
Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment
Paper
Managing unwanted immunogenicity of therapeutic proteins
Blog
I Saw the Future and the Future is Biomarkers
Blog
BioAgilytix: From Solution Provider to Problem Solver
Datasheet
BioAgilytix Scientific Focus: Biomarkers
Blog
Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses
Blog
Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation
Webinar
Webinar Recording: Considerations for Evaluation of Accuracy, Parallelism and Reagent Lot to Lot Variability in Single and Multiplex Biomarker Ligand-Binding Assays
Blog
Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?
Blog
Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers
Article
Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Paper
2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity
Blog
Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis
Webinar
AAPS Webinar Recording: Bioanalytical Methods in Support of Biosimilar Drug Development
Datasheet
BioAgilytix Scientific Focus: Cell-Based Assays
Blog
What a Year! Looking Back at What’s Driving Us Forward in 2017
Paper
Humoral Immune Response to AAV
Blog
Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success
Blog
CRO Communication: Responsiveness for Better Bioanalytical Results
Blog
In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?
Blog
Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other
Datasheet
BioAgilytix Scientific Focus: Immunogenicity
Datasheet
BioAgilytix Scientific Focus: Pharmacokinetics (PK)
Blog
What You Won’t Learn in School: Advice to Early Career Scientists
Blog
Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges
Blog
Biomarker Development: Clearing the Way for Faster Biomarker Innovation
Blog
BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’
Blog
The Importance of Parallelism in Biomarker Assay Development
Blog
Toxicology and Agatha Christie: An Arresting Pairing
Blog
‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis
Blog
Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies
Guidance
Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016
Guidance
EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015
Guidance
Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015
Guidance
Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015
Guidance
EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014
Blog
What’s Your System for Cell-Based Assay Method Selection?
Paper
Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
Paper
Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study
Blog
Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays
Blog
Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory
Paper
B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera
Blog
Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead
Article
How to win client trust as a CRO
Article
Running a successful CRO
Article
How to set up a successful CRO by surrounding yourself with the right team members
Article
Starting a CRO on Personal Credit
Video
Virtual Podium: Biomarkers for Heart Disease in African American Women with Lupus
Video
Virtual Podium: Biomarkers and Alzheimer’s Disease
Video
Virtual Podium: Seeking the Biomarkers of Alzheimer’s Disease – On Our Mind
Video
Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity
Paper
The quintessence of immunogenicity reporting for biotherapeutics
Paper
Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein
Video
Virtual Podium: How is Your Assay Performing? Biomarker Validation Best-Practices
Video
Virtual Podium: An Analytical Approach to Platform Comparison
Video
Virtual Podium: What’s Your System for Cell-Based Assay Method Selection
Paper
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)
Paper
7th GCC Insights: Incurred samples use, solution stability, and more
Paper
Case Studies: Challenges of Supporting Comparability Work for Biosimilars
Paper
7th GCC Insights: incurred samples use; fitfor- Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing
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
Article
Parallelism and Matrix Interference: The Importance of Nomenclature (Part 1)
eBook
Bioanalytical Buyer’s Guide
Paper
Recommendations on incurred sample stability (ISS) by GCC
Article
Growing Clinical Biomarker Assays
Paper
Potential induction of anti-PEG antibodies – PEGylated therapeutics
Paper
Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations
Paper
8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Paper
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Paper
Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
Paper
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations
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
Webinar: Assay and Kit Lot Considerations for Single and Multiplex Biomarker Analysis
Article
Development and validation of an alpha fetoprotein immunoassay
Article
Implementation of a universal analytical method in early-stage development of human antibody therapeutics
Article
Validation of a Gyrolab™ assay for quantification of rituximab in human serum
Paper
Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
Article
Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
Paper
2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS
Paper
Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab
Paper
Immune responses to AAV vectors: overcoming barriers to successful gene therapy
Paper
Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer
Paper
Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
Paper
Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
Guidance
FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013
Paper
In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes)
Paper
Biosimilars: what clinicians should know
Paper
Setting the stage for biosimilar monoclonal antibodies
Guidance
EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012
Paper
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
Paper
Recommendations on biomarker bioanalytical method validation by GCC
Video
Virtual Podium: Western Blot Protocol
Paper
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Paper
Immunogenicity assays and comparability studies in biosimilar drugs
Paper
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines
Paper
Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs by Global CRO Council for Bioanalysis (GCC)
Paper
6th GCC – “Focus on Ligand-Binding Assays”
Poster
Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies
Paper
Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Paper
Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process
Guidance
FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, 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
Paper
Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents
Paper
Ligand Binding Assays in the 21st Century Laboratory: Automation
Paper
Ligand Binding Assays in the 21st Century Laboratory: Platforms
Paper
Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis
Poster
The Determination of Cardiac Toxicity Biomarkers in Rat Serum
Poster
Evaluation of Multiplex Electrochemiluminescent Immunoassays for Quantitative Determination of Kidney Injury Biomarkers in Rat Urine
Paper
Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
Guidance
EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010
Guidance
EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009
Guidance
EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009
Guidance
EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007
Guidance
EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005
Guidance
EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002
Guidance
FDA Guideline on validation of bioanalytical methods, May 2001
Guidance
ICH Q2B Guideline Validation of Analytical Procedures Methodology
Guidance
ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals