Best practices in bioassay development to support registration of biopharmaceuticals

Best practices in bioassay development to support registration of biopharmaceuticals

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 acti...

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Bibliographic Details
Main Authors: 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 SE Stokes, Jeffrey J Talbot, Pin Yee Wong
Format: Article
Language:English
Published: Taylor & Francis Group 2019-09-01
Series:BioTechniques
Subjects:
best practice
bioassay
biologicals
control
development
outlier
Online Access:https://www.future-science.com/doi/10.2144/btn-2019-0031

Internet

https://www.future-science.com/doi/10.2144/btn-2019-0031

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