title: The role of assay validation in specification development.
abstract: Three of the main components that contribute to the establishment of specifications relate to manufacturing consistency, clinical experience, and assay performance. The validation of an analytical control system for biotechnology pharmaceutical products represents a diverse analytical challenge. This paper focusses on the key components of assay validation and how they influence specification design. In particular, issues relating to precision, accuracy, and specificity are discussed in the context of their influence and impact on specification design. Specific examples are presented that encompass assays that are used for purity and potency and their interrelationships.
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Baffi
mesh_terms: D000596:Amino Acids / Q000032:analysis; D000818:Animals; D001681:Biological Assay / Q000592:standards; D001702:Biopharmaceutics / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D002623:Chemistry Techniques, Analytical / Q000379:methods; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D004341:Drug Evaluation / Q000592:standards*; D005069:Evaluation Studies as Topic; D019382:Human Growth Hormone / Q000737:chemistry / Q000302:isolation & purification / Q000494:pharmacology / Q000592:standards; D006801:Humans; D007118:Immunoassay / Q000592:standards; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D011786:Quality Control; D051381:Rats; D011994:Recombinant Proteins / Q000737:chemistry / Q000302:isolation & purification / Q000494:pharmacology / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D015430:Weight Gain / Q000187:drug effects
chemical_list: D000596:Amino Acids; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins; D019382:Human Growth Hormone