Best Practices in Bioassay Development to Support Registration of Biopharmaceuticals | Zendy

John R. White | Zendy; Marla Abodeely | Zendy; Sammina Ahmed | Zendy; Gaël Debauve | Zendy; Evan Johnson | Zendy; Debra M. Meyer | Zendy; Ned M. Mozier | Zendy; Matthias Naumer | Zendy; Alessandra Pepe | Zendy; Isam Qahwash | Zendy; Edward Rocnik | Zendy; Jeffrey G. Smith | Zendy; Elaine S. E. Stokes | Zendy; Jeffrey J. Talbot | Zendy; Pin Yee Wong | Zendy

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Best Practices in Bioassay Development to Support Registration of Biopharmaceuticals

Author(s) -

John R. White,

Marla Abodeely,

Sammina Ahmed,

Gaël Debauve,

Evan Johnson,

Debra M. Meyer,

Ned M. Mozier,

Matthias Naumer,

Alessandra Pepe,

Isam Qahwash,

Edward Rocnik,

Jeffrey G. Smith,

Elaine S. E. Stokes,

Jeffrey J. Talbot,

Pin Yee Wong

Publication year - 2019

Publication title -

biotechniques

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.617

H-Index - 131

eISSN - 1940-9818

pISSN - 0736-6205

DOI - 10.2144/btn-2019-0031

Subject(s) - bioassay , biochemical engineering , drug discovery , drug development , quality (philosophy) , microbiology and biotechnology , computer science , computational biology , risk analysis (engineering) , biology , engineering , business , pharmacology , bioinformatics , drug , ecology , philosophy , epistemology

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.

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