Developments in Biologicals / The Design and Analysis of Potency Assays for Biotechnology Products
National Institute for Biological Standards and Control, London, October 2000
Published on 23. April 2002
Book
Paperback/Softback
VIII, 144 pages
978-3-8055-7425-9 (ISBN)
Description
The complexity of the structure and function of many biotechnology-derived products necessitates a wide range of analytical procedures to adequately characterize the product. Physicochemical techniques provide little, if any, information regarding the potency of biologicals. Therefore, the development and analysis of biological assays that measure the ability of a material to elicit a function are essential to successful product development. Bioassays such as in vivo or cell-based assays often exhibit inherent variability due to the use of living materials. It is necessary to design and execute bioassays to reduce variability as much as possible whilst enabling statistically valid measures of the reproducibility of potency estimates. The manuscripts in this volume aim to describe statistical approaches currently being used in the design and analysis of potency assays for biotechnology products, and to identify factors influencing the appropriate choice of these approaches.
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Content
Session I General Assay Performance Characteristics - Statistical Measures: Characterization and Implications of Bioassay Variation, Ostland, M.; Strip-Plot Designs, Mixed Models, and Comparison between Linear and Non-Linear Models for Microtitre Plate Bioassays,Lansky, D.; Validation of Biological Assays; Schofield, T. Session II Potency Estimation by Parallel Line Bioassay Techniques: Statistical Considerations in the Design and Analysis of Parallel Line Assays, Gaines Das, R.E.; Selected Topics in Parallel Line Bioassay, Giltinan, D.; Parallel Line Bioassay in Practice, Norwood, B.J.; A Case Study; Development of a Bioassay for IL-1ra, Wolf, J.. Session III Extensions to Parallel Line Bioassay Analysis: Constrained Four Parameter Logistic Model, Altan, S., Manola, A., Davidian, M., Raghavarao, D.; An Aspect of Discrete Data Analysis - Fitting a Beta-Binomial Distribution to the Hospitals' Data, Altham, P.M.E. Session IV Special Cases for Assay Design and Analysis: Methods for the Analysis and Design of Limiting Dilution Assays, Matthews, J.N.S.; Analysis of an in vivo Assay for Inactivated Polio Vaccine, Heath, A.B. Session V Analysis to What Aims? Setting Specifications: Setting Specifications for Potency Assays - Basic Principles, Mire-Sluis, A.; Statistical Approaches to Specification Setting with Application to Bioassay, Dillard, B.; International Specification Setting - EP Perspectives, Calam, D.H.