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Biotechnology and Applied Biochemistry (2001) 34, (195–197) (Printed in Great Britain)

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Editorial

Approach to assay validation for the development of biopharmaceuticals

Roger L. Lundblad¹

Editor-in-Chief, Biotechnology and Applied Biochemistry, P.O. Box 16695, Chapel Hill, NC 27516-6695, U.S.A.

Key words: assay accuracy, process validation, product development, assay sensitivity, revalidation.

Abbreviations used: cGMP, current Good Manufacturing Practices; ICH, International Conference on Harmonization.

¹To whom correspondence should be addressed (r.lundblad@worldnet.att.net).

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').

Portland Press Ltd © 2001