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Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytica
Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com
The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved
Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies
This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current
Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism a
The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin ab
Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods, Fifth Edition supplies new chapters on topics currently impacting the field including cutaneous metabolism, skin contamination, exposure to protein allergens, in vitro absorption methodology and the percutaneous absorption of chemical mixtures. Complete with studies on the role of the skin as a key portal of entry for chemicals into the body, this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel. Key Features: Details in vivo and in vitro methods for measuring absorption, dermal decontamination, mechanisms of transdermal delivery, and the relationship of transepidermal water loss to percutaneous absorption Considers a range of mathematical models, the safety evaluation of cosmetic ingredients, the absorption of hair dyes, nanoparticles for drug delivery, and other novel methods of drug delivery Discusses topics including skin metabolism, the skin reservoir, and the effects of desquamation on absorption