2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘ Scientific ’? (Part 1 – LCMS: Small Molecules, Peptides and Small Molecule Biomarkers)

Abstract

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies’ Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively.

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

“…What are the regulatory expectations for hybrid assay BMV? Real world clinical PK data confirm the recommendations of the 2015-2018 White Papers in Bioanalysis [10,13,16,19]. How are these recommendations translated in the ICH M10 draft guideline?…”

“…), performing adequate monitoring of IS across runs/batches/studies, data interpretation, identification of anomalies and troubleshooting? Should the ICH M10 guideline consider previous White Paper recommendations on this topic [10,16]?…”

“…Over the years hybrid LBA/LCMS has gained increasing acceptance in the drug development industry as a complementary, alternative, or even a preferred, bioanalytical approach to conventional LBA for quantification of protein therapeutics and protein biomarkers [10,13,16,19]. With the hybrid LBA/LCMS data reported so far positively demonstrating the robustness of assay performance, bioanalytical scientists are motivated to expand its application in the regulated environment.…”

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

“…However, this new verbiage is not recognized by regulators and by many in the industry who believe that another synonym for FFP validation is not really needed [33]. Hence, only the term 'FFP validation' was used at both the GCC Closed Forum and CRO-Pharma scientific interchange meetings.…”

2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)

“…The regulators' expectations for stability data to be submitted have not changed, and for the most part, industry has complied with the Notice. Refer to Part 1 of the 2017 White Paper for further details [40].…”