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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 1: Neutralizing Antibody (NAb) Detection

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

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

Platform Spotlight: ELISA, Still the Most Used Immunoassay Platform to Support Large Molecule Bioanalysis

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

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis

Leading the Way in Large Molecule Bioanalysis, Our Way

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

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis

Considerations to Set ADA Cut Points

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

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

Cell-Based Assays Keep Biosimilars on Track

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 2: Work Planning and Vendor Selection

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis

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

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

Managing unwanted immunogenicity of therapeutic proteins

I Saw the Future and the Future is Biomarkers

BioAgilytix: From Solution Provider to Problem Solver

BioAgilytix Scientific Focus: Biomarkers

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

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

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

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

Meeting the rigorous demands of biosimilar pharmacokinetics

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

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

BioAgilytix Scientific Focus: Cell-Based Assays

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

Humoral Immune Response to AAV

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

Changing the Dialogue on CRO Communication: Responsiveness for Better Bioanalytical Results

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

BioAgilytix Scientific Focus: Immunogenicity

BioAgilytix Scientific Focus: Pharmacokinetics (PK)

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

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

New Paths for Biomarker Development: Clearing the Way for Faster Innovation

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

The Importance of Parallelism in Biomarker Assay Development

Toxicology and Agatha Christie: An Arresting Pairing

‘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

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

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

Guidance 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

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?: Factors in Assessing the Most Advantageous Model for Your Needs

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

Serum pharmacokinetics and cerebrospinal fluid concentration 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

BioAgilytix advanced quality GLP aboratory

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

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

Running a successful CRO

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

Starting a CRO on personal credit

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

Virtual Podium: Biomarkers and Alzheimer’s Disease

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

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity

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

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

Virtual Podium: An Analytical Approach to Platform Comparison

Virtual Podium: The Present and Future of Biosimilars: Opportunity Abounds

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

Platform Comparisons Guide

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

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars

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

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

Bioanalytical Buyer’s Guide

Recommendations on incurred sample stability (ISS) by GCC

Growing Clinical Biomarker Assays

Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics

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

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

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

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

Development and validation of an alpha fetoprotein immunoassay using Gyros technology

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

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

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

FDA Guidance for Industry: Bioanalytical Method Validation, September 2013

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

Inhibition of oncogenic Pim-3 kinase modulates transformed growth and chemosensitizes pancreatic cancer cells to gemcitabine

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

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

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

In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes): a promising new tool for tolerance induction and treatment of autoimmunity

Biosimilars: what clinicians should know

Setting the stage for biosimilar monoclonal antibodies

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

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

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)

Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development

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

6th GCC – “Focus on LBA”: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies

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

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 in the 21st Century Laboratory: 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: Platforms

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

Evaluation of the MSD Multiplex Electrochemiluminescent Immunoassay for the Determination of Cardiac Toxicity Biomarkers in Rat Serum

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

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

FDA Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins, December 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 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 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

ICH Q2B Guideline Validation of Analytical Procedures Methodology

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals