Process validation for the production of biopharmaceuticals

Principles and best practice
Erscheinungsjahr 2013
ISBN: 978-1-907568-64-0
Verlag: Woodhead Publishing

Buch, Englisch, Band 34, 250 Seiten

Reihe: Woodhead Publishing Series in Biomedicine

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.

Autoren/Hrsg.

Newcombe, A R

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

The Validation Master Plan (VMP); Process characterisation; Quality risk management; Buffer stability; Validation support studies; Cell culture (upstream); Drug product validation; Evaluating validation success post PV batch review and data analysis; Process analytics.

Über Autor(innen)

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.