[PDF] Bioseparation And Bioprocessing Volume I Biochromatography Membrane Separations Modeling Validation Volume Ii Processing Quality And Characterisation Economics Safety And Hygiene eBook

Author : G. Subramanian
Publisher : Wiley-VCH
Page : 568 pages
File Size : 17,74 MB
Release : 1998
Category : Science
ISBN :

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Rapid developments in biotechnology create a demand for practical, up-to-date reviews written by and for experts in industry. This compact handbook provides all relevant up-to-date information on important bioseparation and bioprocessing techniques that are actively applied in the biotechnology industries. The handbook presents an applications-orientated overview on - case studies and general strategies for quality control and characterization - detailed guidelines on developing economic and technically feasible bioseparation schemes - strategies and methods for intracellular bioproduct release - chromatographic and membrane downstream processes used in biotechnology - applications of modern non-invasive methods such as neural networks for on-line estimation and control of fermentation variables on an industrial scale - a practical, commercially-relevant guide to biosafety and many more aspects which are indispensible for present and future industrial success.

Author : Sarfaraz K. Niazi
Publisher : CRC Press
Page : 612 pages
File Size : 40,49 MB
Release : 2016-01-05
Category : Medical
ISBN : 1498743501

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What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th

Author : Anurag S. Rathore
Publisher : CRC Press
Page : 535 pages
File Size : 29,62 MB
Release : 2012-05-09
Category : Medical
ISBN : 1439850933

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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Author : Gunter Jagschies
Publisher : Elsevier
Page : 383 pages
File Size : 11,97 MB
Release : 2007-12-08
Category : Technology & Engineering
ISBN : 0080554512

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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 systems New 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 assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design

Author : Ganapathy Subramanian
Publisher : Wiley-VCH
Page : 0 pages
File Size : 42,34 MB
Release : 2007-11-20
Category : Science
ISBN : 9783527315857

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In this new edition of the only resource to systematically cover all post-production issues, over 70% of the content is new or rewritten in line with the rapidly evolving technology in the field. By combining the experience of academic experts, managers from the pharmaceutical and biotech industry, as well as independent consultants, biological product recovery is viewed from every possible angle, including biosafety and regulatory issues.

Author : Abhinav A. Shukla
Publisher : CRC Press
Page : 600 pages
File Size : 19,2 MB
Release : 2006-07-07
Category : Medical
ISBN : 1420016024

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The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut

Author : C.A. Costa
Publisher : Springer Science & Business Media
Page : 465 pages
File Size : 14,1 MB
Release : 2012-12-06
Category : Science
ISBN : 9401134707

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Separation processes in biotechnology are of increasing industrial importance since they entail the major costs of bioprocessing especially when high purity is required. Chromatography and membranes are two of the most important technologies used for direct treatment of fermentation broths as well as for high resolution steps in product purification. The theoretical foundations of chromatographic and membrane processes are well understood for the case of small molecules. Nevertheless there is a need to adapt and further develop that knowledge to the processing of large biological molecules. This is being achieved with the contribution of other areas like molecular biology and materials science. The objective of this NATO Advanced Study Institute is to present an updated treatment of the fundamentals of chromatographic and membrane processes with special relevance in bioprocessing.This volume collects the lectures presented at this Institute. The lectures are arranged in five chapters. Chapter I deals with chromatographic processes covering topics like equilibrium, kinetics and contacting devices. Membrane processes and some applications in biotechnology are treated in chapter 2. Chapter 3 is devoted to affinity chromatographic and membrane processes. Chapter 4 considers the current developments on chromatographic supports and membranes both from the constitutive materials and form points of view. Scale-up, optimization and reaction/separation integration are the topics covered in chapter 5. We are very grateful to all lecturers and participants that made possible this Institute. Financial support from NATO Scientific Affairs Division, INIC, JNICT, FLAD, University of Ac;ores and DRT Ac;ores is gratefully acknowledged.