Written by global subject matter experts, this book offers the practical experience needed to obtain a competitive edge. The successful technology transfer from research and development to the commercial production site is a critical process in the development and launch of a new medicinal product. An unsuccessful transfer can result in possible launch delays and lost sales as well as require increased resources, time and money to make corrective actions. This book will help companies take a proactive approach to streamlining and optimizing their technology transfer processes to ensure success.
Book written in May, 2014
Table of Contents:
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- Introduction and Objectives by Mark Gibson and Siegfried Schmitt
- Technology Transfer and Knowledge Management Over the Drug Lifecycle by Siegfried Schmitt
- Technology Transfer, The Regulatory and Business Perspective by Alan Harris and Siegfried Schmitt
- Technology Transfer Organisation Strategy and Planning by Steve Burns and Mark Gibson
- Chemical Drug Substance Development and Technology Transfer by Alan Harris
- Chemical Drug Product Development and Technology Transfer by Mark Gibson
- Drug Substance Manufacturing Process Development and Technology Transfers — Biopharmaceuticals by Lamine Bouakaz
- Analytical Methodology and Specifications by Mark Hindle
- Appendix: Special Considerations for Transfer of Bioassay Methods by Sharon Longhurst and Ralf Hess
- Technology Transfer, Outsourced Activities Management by Siegfried Schmitt
- Audits and Inspections by Mark Gibson
- Training, An Essential Element of Technology Transfer by Siegfried Schmitt
About the Editors
Mark Gibson, BPharm, PhD, CChem, MRSC, MRPharmS, is currently an Independent Consultant to the Pharmaceutical Industry. His experience encompasses 30 years working in the pharmaceutical industry, both as a bench scientist and a manager, in the development of new chemical entities and line extensions for American Cyanamid (Lederle), Fisons Pharmaceuticals, Astra Pharmaceuticals and AstraZeneca. Over this time, he has worked on a wide range of formulation types and routes of delivery, including inhalation, oral, nasal, ophthalmic, parenteral and transdermal, some of which have resulted in patents and marketable products. He has extensive experience of product development and working within different technology transfer operational guidelines and transferring drug product manufacturing processes from R&D into different production sites around the world. Over the years, Dr. Gibson has presented widely on a range of topics, including technology transfer, at conferences, seminars and scientific meetings. He has authored and edited several books and scientific papers for journals. He is a member of the Royal Pharmaceutical Society, the Royal Society of Chemistry and a Board Member of the Parenteral Drug Association (PDA) UK Chapter.
Siegfried Schmitt, PhD MSc CSci CChem FRSC, is a Principal Consultant with PAREXEL Consulting which he joined in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. He is the PAREXEL practice lead for Quality by Design. He started his career in 1989 with Roche in Basel, Switzerland, where he worked as Senior Production Chemist. This was followed by positions with Raytheon as Validation Manager, ABB as Senior Lead Consultant and GE Healthcare as global Quality Director, before joining PAREXEL.
During his 25 year career he has been involved in product and process development, followed by technology and know-how transfers, often between different legal and regional entities. His particular interests are in robust, agile, effective and efficient quality systems that support technology transfer.
Dr Schmitt is an accomplished author, editor and presenter, having won the coveted "distinguished PDA author/editor award" in 2008 and 2012. He publishes regularly and is a member the editorial advisory boards for PDA Letter, Pharmaceutical Technology, Journal of Validation Technology and RAPS Focus (chairman). He is an active member of several industry associations, including the Royal Society of Chemistry, Parenteral Drug Association (UK Chapter president and member of RAQAB), Regulatory Affairs Processionals Society, International Society for Pharmaceutical Engineering and the Drug Information Association.