The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?

Natural Products, broadly defined as high value chemical entities derived from plants or microbial sources, have been known and exploited for many years. In recent years, as the need for higher potency and predictability of such products has increased, more sophisticated concentration and isolation procedures have been developed. With the passage of time, such procedures have been rationalized in terms of scientific principles but, in general, theory has followed behind practice, leading at any given time to an absence from the literature of methods which are truly state of the art. Downstream Processing of Natural Products: A Practical Handbook is a highly practical manual which addresses this issue, and guides researchers and industrial workers through the many potential pitfalls of natural product isolation. The contributors to this volume, all of whom have wide practical experience in this field, present state-of-the-art techniques and observations. The three main stages of natural product purification are covered, namely product release, capture, and purification, and both proteins and secondary metabolites are covered. There is special mention of the requirements of the regulatory authorities with respect to Good Manufacturing Practice, and practical guidance is given on scale-up procedures and process scale instrumentation. Downstream Processing of Natural Products: A Practical Handbook will provide essential practical guidance to all those involved in natural product isolation. This includes academic and industrial researchers, postgraduate students and technicians working in the biotechnology field.

This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design

Handbook of Biofuels looks at the many new developments in various type of bioenergy, along with the significant constraints in their production and/or applications. Beyond introducing current approaches and possible future directions of research, this title covers sources and processing of raw materials to downstream processing, constraints involved and research approaches to address and overcome these needs. Different combinations of products from the biorefinery are included, along with the material to answer questions surrounding the optimum process conditions for conversion of different feedstocks to bioenergy, the basis for choosing conversion technology, and what bioenergy products make economic sense. With chapters on the techno-economic analysis of biofuel production and concepts and step-by-step approaches in bioenergy processing, the objective of this book is to present a comprehensive and all-encompassing reference about bioenergy to students, teachers, researchers and professionals. - Reviews all existing and emerging technologies surrounding the production of advanced biofuels, including biodiesel and bioethanol - Includes biofuel applications with compatible global application case studies - Offers new pathways for converting biomass

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

Proteins are important biomolecules that are vital for the cellular structure and function. They perform a vast array of functions within organisms, including the catalysis of metabolic reactions, DNA replication, response to stimuli, and transporting molecules from one location to another. The technological advances in the omics areas (e.g., genomics, transcriptomics, proteomics, metagenomics, etc.) have dramatically increased the rate of discovering new proteins. Some of them hold large opportunities for innovative research and the development of commercial products and applications. It is worth noting that the global protein ingredients market is poised to grow over the next decade to reach approximately 58.49 billion USD by 2022, with the protein therapeutics market valuing around USD 315.9 billion by 2025. Interestingly, about seventy monoclonal antibody products will be on the market by 2020 with a combined worldwide sales of about 125 billion USD.The most significant parameter for the successful commercial exploitation of proteins rely on the development of an efficient and effective isolation and purification technology, known as protein downstream processing. Downstream processing refers to the technology that involves the isolation and production of purified products from natural sources such as animal tissues, plant tissues, microorganisms or fermentation broth. The most important element of this technology is the high purification processes, most important of which is chromatography and in particular affinity chromatography.This book provides information on the resent developments of protein downstream processing and deals with the information gained over the last years from the application of protein purification technologies on different research areas. Each chapter gives key examples that cover a wide range of diverse scientific disciplines in order to provide the reader with a representative sample of the current status of the field. The present book would definitely be an ideal source of scientific information to the advanced students, junior researchers, and scientists involved in cellular and molecular biology, biochemistry, microbiology, biotechnology and other related areas.

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference