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Explore the array of scientific resources we’ve developed, the publications and papers we’ve contributed to, and more.
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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
Blog
BioAgilytix Team Q&A: Meet Samuel Pine, Director of Bioanalytical Operations, Europe
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
Datasheet
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
Evaluating the Immunogenicity of Antibody-Drug Conjugates
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
Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves
Article
Immunogenicity Considerations for Antibody–drug Conjugates: 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
Business of Bioanalysis: 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
Business of Bioanalysis: 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
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 Immunoassays 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
Platform Spotlight: ELISA, Still the Most Used Immunoassay Platform to Support 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
Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis
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 Evolving 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, Part 2: 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 Innovative Therapeutic Options for Treating Human Cancers
Article
Meeting the rigorous demands of biosimilar pharmacokinetics
Paper
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (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
Changing the Dialogue on 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: Real-World Advice to Early Career Scientists
Blog
Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges
Blog
New Paths for Biomarker Development: Clearing the Way for Faster 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?: Factors in Assessing the Most Advantageous Model for Your Needs
Paper
Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
Paper
Serum pharmacokinetics and cerebrospinal fluid concentration 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: The Present and Future of Biosimilars: Opportunity Abounds
Video
Virtual Podium: What’s Your System for Cell-Based Assay Method Selection
eBook
Platform Comparisons Guide
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; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Paper
Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars
Article
Parallelism and Matrix Interference: The Importance of Nomenclature (Part 1)
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
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 and complement activation toward 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 Bridging Considerations for Single and Multiplex Biomarker Analysis
Article
Development and validation of an alpha fetoprotein immunoassay using Gyros technology
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
Guidance
FDA Guidance for Industry: Bioanalytical Method Validation, September 2013
Paper
Immune responses to AAV vectors: overcoming barriers to successful gene therapy
Paper
Inhibition of oncogenic Pim-3 kinase modulates transformed growth and chemosensitizes pancreatic cancer cells to gemcitabine
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): a promising new tool for tolerance induction and treatment of autoimmunity
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
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
Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
Paper
2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines
Paper
6th GCC – “Focus on LBA”: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Poster
Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies
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 in the 21st Century Laboratory: 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
Evaluation of the MSD Multiplex Electrochemiluminescent Immunoassay for 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
FDA Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins, December 2009
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