Last edited by Malkis
Thursday, July 23, 2020 | History

4 edition of The Design and Analysis of Potency Assays for Biotechnology Products found in the catalog.

The Design and Analysis of Potency Assays for Biotechnology Products

National Institute for Biological Standards and Control, London, U. K. Octo00 (Developments in Biologicals)

by Anthony Mire-Sluis

  • 341 Want to read
  • 16 Currently reading

Published by Not Avail .
Written in English

    Subjects:
  • Pharmaceutical technology,
  • Pharmacology,
  • Biotechnology,
  • Immunology,
  • Pharmacy,
  • Pharmaceutical Biotechnology Products,
  • Medical

  • Edition Notes

    ContributionsFred Brown (Editor)
    The Physical Object
    FormatPaperback
    Number of Pages144
    ID Numbers
    Open LibraryOL12931432M
    ISBN 103805574258
    ISBN 109783805574259

    A bioassay is an analytical method to determine concentration or potency of a substance by its effect on living cells or tissues. Bioassays are quantitative biological assays used to estimate the potency of agents by observing their effects on living animals (in vivo) or tissue/cell culture systems (in vitro).. A bioassay experiment can either be qualitative or quantitative, direct or . Potency is a critical quality attribute of a biological product and is often determined by a biological assay (also called bioassay or biopotency assay).Specifically, potency is the biological activity or capacity of a product directly linked to its clinical efficacy. Potency tests are performed as part of product release, comparability studies, and stability testing.

    POTENCY ASSAYS. Overcoming the Limits and Variability of Cell and Gene Therapy Potency Assays. Win Cheung, PhD, Associate Director, Analytical Development, REGENXBIO. The development and validation of robust potency assays continues to be a significant challenge in the preclinical development of cell and gene therapies.   In this webinar, PPD's experts share a case study for a biological drug product that required re-development of the bioassay method for potency and an improved process for extracting the drug.

    The potency of several Pharmacopeial drugs must be determined by bioassay. A controlling factor in assay design and analysis is the variability of the biological test system, which may vary in its mean response from one laboratory to another, and from time to .   Book. TOC. Actions. Share. manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. the Design and Analysis of Replicate‐Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays (Pages.


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The Design and Analysis of Potency Assays for Biotechnology Products by Anthony Mire-Sluis Download PDF EPUB FB2

The Design and Analysis of Potency Assays for Biotechnology Products: National Institute for Biological Standards and Control, London, U. Octo00 (DEVELOPMENTS IN BIOLOGICALS) Paperback – May 1, Author: Anthony Mire-Sluis.

PotencyEstimation byParallel Line BioassayTechniques 33 Statistical Considerations in the Design andAnalysisofParallelLineAssays 35 R.E. GainesDas SelectedTopics in ParallelLineBioassay 47 D.

Giltinan ParallelLineBioassayinPractice 57 d ACaseStudy: Developmentof a BioassayforEL-lra 63 J. Wolf SessionIII Extensions to Parallel Line. Potency assays are used to characterize the product, to monitor lot-to-lot consistency, and to assure stability of the product.

Potency may be measured by a binding assay, a serologic assay. 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.

•Setting Specifications for Potency Assays – Basic Principles. Mire-Sluis, AR, in: The Design and Analysis of Potency Assays for Biotechnology Products. Brown and Mire-Sluis (eds). Dev Biol (Basel). •Progress in the Use of Biological Assays during the Development of Biotechnology Products.

Mire-Sluis, AR. Pharm. Res.,File Size: KB. 4 Examples of Potency Assays The Importance of Potency •You cannot confirm stability without a potency assay • Biological function may be lost before viability •Viability alone doesn’t confirm the product is effective, you need a potency assay.

•Compatibility of the product with devices (e.g. syringes, containers, etc) or otherFile Size: KB. 3 Design and Development of Biological Assays. 9 General Chapter Design and Analysis of Biological Assays, that is now official in 10 the US Pharmacopeia (USP). The partitioning of chapters to different aspects of Potency is a stability-indicating parameter of biotechnology and vaccine products.

Potency testing is an important part of the evaluation of cellular therapy products. Potency assays are quantitative measures of a product-specific biological activity that is linked to a relevant biological property and, ideally, a product's Cited by: potency assay or assay matrix design and acceptance criteria should establish appropriate limits for potency to assure that product lots are well.

Directions for calculating potency from the data of a single assay are given in the individual monographs. In those assays that specify graphical interpolation from dosage-response curves but that meet the conditions for assay validity set forth herein, potency may be computed alternatively by the appropriate method in this section.

The design and analysis of potency assays for biotechnology products: National Institute for Biological Standards and Control, London, U.K., Octoberproceedings of a symposium co-sponsored by the International Association for Biologicals (IABs), the World Health Organization (WHO), and the International Union of Immunological Societies (IUIS).

By using the bioassay procedure, the cell system, and the allied reference material, manufacturers, regulatory officials, and many others will soon have a comprehensive approach to ensure up-to-date measurement of the potency of biological and biotechnology-derived products.

This potency is measured in units/mass of drug substance and should be consistent for a manufacturer's product over time, across manufacturers making the same product.

The design and analysis of potency assays for biotechnology products: National Institute for Biological Standards and Control, London, U.K. October   Principles of vaccine potency assays.

Thorsten Verch, Jeremiah J Trausch & Mary Shank-Retzlaff; The biomanufacturing of biotechnology products the history of biotechnology and biomanufacturing. In: •• A text book focusing on vaccine analytical development and by: 1.

Abstract. The complexity of the structure and function of many biotechnology derived products necessitates a wide range of analytical procedures to adequately characterize the product. In-depth characterization is required for the assessment of several criteria vital to the success of product development such as consistency, purity, stability, Cited by: The development of in vitro potency assays for CGT products includes at least two steps.

First: It must be demonstrated that the vector can transfer genetic material into a cell. Potency assays are used to measure the ability of a drug to elicit a particular response at a certain dose in a relevant biological system. Potency assays are usually required by regulatory agencies for release of drug product under GMP.

They are also useful in drug discovery to rank potential therapeutic candidates. In defining bioassays and relative potency, the United States Pharmacopeia (USP) states (1): “Because of the inherent variability in biological test systems (including that from animals, cells, instruments, reagents, and day-to-day and between-lab).

Thus the analytical development group will support methods for cell culture, fermentation, assay to determine titers or process yields as well as bioassays, and other assays to elicit the identity, potency, purity, and safety of the product (e.g., in monoclonal antibodies [mAbs]) to use size exclusion chromatography (SEC) to determine the Cited by: 7.

The use of experimental design, incorporating factors which may be a source of assay variability, is advocated by regulatory authorities and will become increasingly used for qualification and validation of cell-based potency assays. Five mock potency values are typically used in bioassay studies and normalizing data to % will provide Cited by: 2.

〈〉 Biological Assays / General Information First Supplement to USP 35–NF 30 General Chapters General Information Add the following: Audience This chapter is intended for both the practicing bioassay 〈〉 DESIGN AND analyst and the statistician who are engaged in developing a bioassay.

The former will find guidance for.Dillard, R.F. () Statistical Approaches to Specification Setting with Application to Bioassay, in: Brown, F., Mire-Sluis, A. (eds) The Design and Analysis of Potency Assays for Biotechnology Products.

Developments in Biological Standards, Basel: Karger GMP cell-based potency testing quantitatively determines the biological activity of a biopharmaceutical. Measurement of potency plays an essential role in quality control, GMP product release and biopharmaceutical stability testing for both drug product and drug substance.

Biological activity or potency is a critical quality attribute that often faces increased scrutiny by .