Best practices in bioassay development to support registration of biopharmaceuticals

BioTechniques

Jeffrey J Talbot¹  Edward Rocnik²  John R White³  Sammina Ahmed⁴  Gaël Debauve⁵  Evan Johnson⁶  Debra M Meyer⁷  Pin Yee Wong⁷  Matthias Naumer⁸  Ned M Mozier⁸  Alessandra Pepe⁹  Jeffrey G Smith^1,10  Elaine SE Stokes^1,11  Marla Abodeely^1,12  Isam Qahwash^1,13 

[1] Analytical Development, Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, NJ 08534, USA;Co. KG, Knollstrasse, Ludwigshafen 67061, Germany;;1Biopharmaceutical Development GlaxoSmithKline R&2Analytical Development Department, Shire, 200 Shire Way, Lexington, MA 02421, USA;3Analytical Services, Lonza Biologics plc, 228 Bath Rd, Slough, SL1 4DX, UK;4Bioassay Development, Analytical Development Sciences for Biologicals, UCB Pharma, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium;5Analytical Development – Biologics, Takeda Pharmaceuticals International Co., 300 Massachusetts Ave, Cambridge, MA 02139, USA;6Biotherapeutics Pharmaceutical Sciences, Pfizer Inc, 700 Chesterfield Parkway West, Chesterfield, MO 63017, USA;;7NBE Analytical R&8Analytical Development Biotech department, Merck Serono SpA, 11 Via Luigi Einaudi, Guidonia Montecelio (RM), 00012, Italy;;9Biologics Development, Molecular &D, 1250 S Collegeville Rd, Collegeville, PA 19426, USA;;D, AbbVie Deutschland GmbH &

关键词: best practice;    bioassay;    biologicals;    control;    development;    outlier;   

DOI  :  10.2144/btn-2019-0031

来源: DOAJ

【 摘 要 】

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

【 授权许可】

Unknown