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Process Validation for the Production of Biopharmaceuticals: Principles and Best Practice

Process Validation for the Production of Biopharmaceuticals: Principles and Best Practice (Hardback)

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Process validation for the production of biopharmaceuticals examines the practical, theoretical and regulatory aspects of process validation relevant to biopharmaceutical production and critically evaluates individual manufacturing unit operations. Chapters provide validation solutions applicable to a variety of commercial biopharmaceutical processes. The text includes a description of validation strategies and aspects of regulatory compliance with industry-focused practical examples. This book considers risk management strategies used for the selection of critical and key process parameters, along with the methodology used to categorise process outputs and define validation acceptance criteria.

BusinessIndustry & industrial studiesManufacturing industriesHi-tech manufacturing industriesScience & MathematicsBiology, life sciencesLife sciences: general issuesTechnicalBiochemical engineeringBiotechnologyTechnicalIndustrial chemistry & manufacturing technologiesIndustrial chemistryPharmaceutical technology Publisher: Elsevier Science & Technology Publication Date: 01/10/2012 ISBN-13: 9781907568640  Details: Type: Hardback Format: Books
Availability: To Order. Estimated despatch in 1-3 weeks.  

Dr Anthony R. Newcombe was the Purification Lead at Pfizer Biotechnology Ireland. He is currently Senior Manager, Process & Product Validation, Global Industrial Operations, GlaxoSmithKline Biologicals, Belgium. He has extensive experience in the technical and operational leadership of development programs to co-ordinate process transfer, scale-up, laboratory scale pre-qualification (design space) studies and the development of effective process validation strategies for biopharmaceutical production. Anthony is a Visiting Professor at the Biopharmaceutical Bioprocessing Technology Centre (BBTC), Newcastle University, member of the Editorial Board, Journal of Protein Expression & Purification, Member of the Royal Society of Chemistry (MRSC) and Scientific Advisor, Technology Transfer Strategy panel at the Wellcome Trust, UK. Dr Piranavan Thillaivinayagalingam is an expert in process characterisation (including QbD approach), technology transfer, scale up and the development, coordination and implementation of process validation strategy for manufacture of biopharmaceuticals. Piranavan is currently the purification expert at Novartis Pharma and prior to this was a Senior Scientist at Pfizer Biotechnology Ireland, responsible for the transfer of phase 3 and commercial processes.

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