Tags

, , , , , , ,

Binodh DeSilvaBinodh DeSilva is the Executive Director of Immunochemistry and Biomarker Development at Bristol-Myer Squibb Company in Lawrenceville, NJ. DeSilva has been an active member of AAPS since 1997. Currently, she is a Member-at-Large on the AAPS Executive committee, the past-chair of the Biotech section of the AAPS, member of the Steering Committee of the Global Bioanalytical Consortium representing North America. She is co-chairing the Crystal City V conference with Drs. Brian Booth, Sam Haidar, and Mark Arnold. Connect with Binodh on LinkedIn at http://www.linkedin.com/pub/binodh-desilva/0/a78/8ba

Since bioanalytical method validation (BMV) study data generally supports regulatory filings, regulatory guidance is necessary to assert the best practices. Historically, the workshop report that came from the first BMV workshop in 1990 was so well received that significant improvements were seen in the “quality of bioanalytical methods and in the submission of pharmacokinetics, bioavailability, and bioequivalence studies” to the Food and Drug Administration. Hence came the need for more action to create better guidance.

It has been almost three years since the Global Bioanalytical Consortium (GBC) was formed with twenty harmonization teams comprising representatives from the United States, Canada, Europe, Japan, China, India, and Brazil. The main scope of the GBC teams was to bring together stakeholders from the pharmaceutical industry, contract research organizations, and academia to share current understanding of bioanalysis guidelines, to identify differences or different interpretations of these guidelines related to regulated bioanalysis, and to come forth with recommendations based on the best practices within the community

The 20 teams addressed three major categories of bioanalysis. Three teams focused on issues and best practices that were exclusive to small molecule liquid chromatography/mass spectrometry assays, such as small molecule run acceptance criteria, small molecule specific assay operations, and chromatographic run quality assessment. Six teams were focused on best practices when conducting ligand binding assays, covering topics like large molecule run acceptance criteria, reagents and their stability, and large molecule specific assay operations. The majority of the teams (11) addressed common issues that pertain to regulated bioanalysis irrespective of the technology platforms, including scope and regulations, method transfer in partial and cross validations, and reference standards and reagents. The GBC teams have worked diligently over the past three years and subsequently produced white papers and commentaries that are compiled into a theme issue of The AAPS Journal.

The recommendations presented in these papers will enable the regulators to understand the current industry best practices on the acceptance criteria, stability evaluations, new technologies that are used within the industry, effect of immunogenicity on the quantification of the large molecule therapeutics, etc. Given that the harmonization teams are represented globally and submissions for drug approvals are becoming global, harmonization of regulated bioanalytical activities will not only enable successful submissions to global regulatory agencies but also reduce the cost greatly. Through all these efforts, the ultimate goal is much needed therapies to the patients in a timely manner.