In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development.
Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development.
Marian Kelley, M.A., Director of Compliance, Department of Clinical Pharmacology & Experimental Medicine, Centocor Inc, PA, USA
Medicines from Animal Cell Culture:Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes
Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.
Methods in Biotechnology engages the reader by implementing an active learning approach, provided advanced study questions, as well as pre- and post-lab questions for each lab protocol. These self-directed study sections encourage the reader to not just perform experiments but to engage with the material on a higher level, utilizing critical thinking and troubleshooting skills.This text is broken into three sections based on level – Methods in Biotechnology, Advanced Methods in Biotechnology I, and Advanced Methods in Biotechnology II. Each section contains 14-22 lab exercises, with instructor notes in appendices as well as an answer guide as a part of the book companion site. This text will be an excellent resource for both students and laboratory professionals in the biotechnology field.
This book also appeals to the lay reader without a scientific background who is interested in an entertaining and informative introduction to the key aspects of biotechnology. Authors Renneberg and Demain discuss the opportunities and risks of individual technologies and provide historical data in easy-to-reference boxes, highlighting key topics. The book covers all major aspects of the field, from food biotechnology to enzymes, genetic engineering, viruses, antibodies, and vaccines, to environmental biotechnology, transgenic animals, analytical biotechnology, and the human genome. This stimulating book is the most user-friendly source for a comprehensive overview of this complex field.Provides accessible content to the lay reader who does not have an extensive scientific backgroundIncludes all facets of biotechnology applicationsCovers articles from the most respected scientists, including Alan Guttmacher, Carl Djerassi, Frances S. Ligler, Jared Diamond, Susan Greenfield, and moreContains a summary, annotated references, links to useful web sites, and appealing review questions at the end of each chapterPresents more than 600 color figures and over 100 illustrationsWritten in an enthusiastic and engaging style unlike other existing theoretical and dry-style biotechnology books