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Approach to assay validation for the development of biopharmaceuticals
Author(s) -
Lundblad Roger L.
Publication year - 2001
Publication title -
biotechnology and applied biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.468
H-Index - 70
eISSN - 1470-8744
pISSN - 0885-4513
DOI - 10.1042/ba20010081
Subject(s) - biochemical engineering , new product development , computer science , process development , process (computing) , manufacturing process , product (mathematics) , process engineering , manufacturing engineering , engineering , materials science , mathematics , business , geometry , marketing , composite material , operating system
The development, manufacture and characterization of biopharmaceuticals requires the use of a variety of analytical procedures. Each assay must be validated to demonstrate that it is suitable for its intended purpose, either as an in‐process analysis for the characterization of critical product/process attributes or final product characteristics. This paper is a brief review of the various considerations required for the validation of an assay procedure for use within Good Laboratory Practices (‘GLP’) or current Good Manufacturing Practices (‘cGMP’).