Lyophilization of Biopharmaceuticals

These considerations include properties of the biopharmaceutical itself and the
intended dosage form . Some of the properties of the drug that need to be
considered include its relative reactivity , pH for optimum stability , and its potency
( i.e. ...

Author: Henry R. Costantino

Publisher: Springer Science & Business Media

ISBN: 0971176760

Category: Medical

Page: 686

View: 609

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Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.
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Immunogenicity of Biopharmaceuticals

Introduction The immune response to biopharmaceuticals is still an elusive
process, governed by a large number of factors. In this chapter an overview is
given of several of the factors implicated in the development of an immune
response, ...

Author: Marco Weert

Publisher: Springer Science & Business Media

ISBN: 9780387758411

Category: Medical

Page: 266

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Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.
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Delivery Technologies for Biopharmaceuticals

Challenges in Delivery of Biopharmaceuticals; the Need for Advanced Delivery
Systems Hanne Mørck Nielsen and Lene ... Denmark 1.1 Introduction Due to the
advances in biotechnology, traditional biopharmaceuticals of biological origin are
 ...

Author: Lene Jorgensen

Publisher: John Wiley & Sons

ISBN: 9780470688403

Category: Science

Page: 442

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Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include: challenges in delivery of biopharmaceuticals novel formulation approaches for peptide and protein injectables non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs immune response, adjuvants and delivery systems for vaccines several examples of delivery systems for different biopharmaceuticals a critical assessment of delivery technologies for biopharmaceuticals Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development.
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Biopharmaceuticals an Industrial Perspective

Chapter 10 Patent Law for Biopharmaceuticals R. Stephen Crespi European
Patent Attorney , West Sussex , UK Key words : Patent , biotechnology ,
biopharmaceutical , litigation Abstract : The patenting of all technological
innovations has to ...

Author: G. Walsh

Publisher: Springer Science & Business Media

ISBN: 0792357469

Category: Medical

Page: 514

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Biopharmaceuticals, an Industrial Perspective provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary. Several chapters overview the production and medical applications of specific biopharmaceuticals. Other chapters detail additional relevant issues, including the stabilisation of biopharmaceutical products, EU biopharmaceutical regulatory affairs and biopharmaceutical patent law. A series of four chapters reviews important validation issues as applied to biopharmaceutical manufacturing. Additional issues considered include biopharmaceutical information technology as well as viral and non-viral gene therapy. The book is of particular relevance to scientists and allied professionals already employed in the biopharmaceutical industry, or to those seeking employment within this industry. Its scope also renders it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry or medicine.
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Production controls recommended by the FDA for biopharmaceuticals
manufactured from transgenic plants . ... List of some APHIS and FDA
requirements for ensuring that plant - based biopharmaceuticals do not enter the
animal or human ...

Author: John Geigert

Publisher: Springer Science & Business Media

ISBN: 0306480409

Category: Medical

Page: 350

View: 159

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"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
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Biopharmaceuticals in Plants

Prospects for Commercial Production and for Global Health 6.1 Introduction In
the past, biopharmaceuticals were produced chiefly by bacterial or yeast
fermentation systems or mammalian cell culture. More recently, transgenic
animals have ...

Author: Kathleen Laura Hefferon

Publisher: CRC Press

ISBN: 1439804753

Category: Medical

Page: 224

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Transgenic plants present enormous potential to become one of the most cost-effective and safe systems for large-scale production of proteins for industrial, pharmaceutical, veterinary, and agricultural uses. Over the past decade, much progress has been made with respect to the development of vaccines, antibodies, and other therapeutic proteins. Bi
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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

BIOPHARMACEUTICALS. AND. VACCINES. Jim Searles and Govindan Mohan
29.1. PROCESS DESCRIPTION Spray drying is a continuous process that
converts a solution or suspension into a powder by drying an aerosol spray of the
 ...

Author: Feroz Jameel

Publisher: John Wiley & Sons

ISBN: 9780470118122

Category: Science

Page: 984

View: 193

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A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
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Approaches to the Conformational Analysis of Biopharmaceuticals

Most biopharmaceuticals are proteins or protein conjugates and are considered
to be biopolymers. Proteins have a unique conformation in solution, which is a
product of diverse covalent and noncovalent interactions. It is generally accepted
 ...

Author: Roger L. Lundblad

Publisher: CRC Press

ISBN: 1439807817

Category: Medical

Page: 366

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The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products. Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen–deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy. Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including: Comparability of biopharmaceuticals Characterization of follow-on biologics Quality attributes of protein biopharmaceuticals Confrontational analysis of biopharmaceutical products With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.
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Biopharmaceuticals

These techniques facilitate the large-scale production of virtually any protein, and
proteins of medical interest produced by these methodologies have been coined '
biopharmaceuticals'. More recent developments in biomedical research ...

Author: Gary Walsh

Publisher: John Wiley & Sons

ISBN: 9781118687383

Category: Medical

Page: 544

View: 831

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The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.
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Biotechnology and Biopharmaceuticals

Cost-Effectiveness: Assessing the Value of Biopharmaceuticals 8.6. Economics
of Biosimilars 8.7. Economic Impact of Personalized Medicine 8.3. The Cost of
Developing Biopharmaceuticals 8.8. Summary and Future Challenges 8.4.
Pricing ...

Author:

Publisher: John Wiley & Sons

ISBN: 9781118659984

Category: Science

Page: 744

View: 830

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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
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Perfusion Cell Culture Processes for Biopharmaceuticals

This book is a monography about perfusion cell cultures for the production of biopharmaceuticals, such as therapeutic proteins (i.e. biomolecules like monoclonal antibodies), and describes the fundamentals, design and operation of these ...

Author: Moritz Wolf

Publisher: Cambridge University Press

ISBN: 9781108480031

Category: Business & Economics

Page: 224

View: 325

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This book is a monography about perfusion cell cultures for the production of biopharmaceuticals, such as therapeutic proteins (i.e. biomolecules like monoclonal antibodies), and describes the fundamentals, design and operation of these processes. Context is given in the first chapters to understand the state-of-the-art of the technology. We then give an overview of the challenges and objectives in operating mammalian cell perfusion cultures and provide guidelines for the design and setup of lab-scale bioreactor systems, and the required control structure to achieve stable operation. Scale-down devices and PAT tools are described in the context of continuous manufacturing and guidelines for process optimization are given using a variety of case studies to illustrate different approaches. Scale-up is also adressed with a strong focus on bioreactor aeration and mixing, shear stress and cell retention device. Finally, a general introduction for the application of mechanistic and statistic models in bioreactor process development and optimization is given in the last chapter.
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Plasmid Biopharmaceuticals

Asa consequence, a vastand multifaceted field emerged— plasmid
biopharmaceuticals—whose ultimate goal isto provide society with a new
rangeof medicinal agents. The book Plasmid Biopharmaceuticals: Basics,
Applications,and ...

Author: Duarte Miguel F. Prazeres

Publisher: John Wiley & Sons

ISBN: 9781118002254

Category: Medical

Page: 608

View: 271

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The book addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of cross-referencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.
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Modern Biopharmaceuticals

14 A Real Success Story: Plantibodies for Human Therapeutic Use Jorg Knablein
, Merardo Pujol, and Carlos Borroto 14.1 Introduction About 80% of the currently
more than 200 biopharmaceuticals were approved after 2000, and more than ...

Author: Jörg Knäblein

Publisher: John Wiley & Sons

ISBN: 9783527669431

Category: Science

Page: 800

View: 926

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This collection of high-profile contributions provides a unique insight into the development of novel, successful biopharmaceuticals. Outstanding authors, including Nobel laureate Robert Huber as well as prominent company researchers and CEOs, present valuable insider knowledge, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects, from the establishment of biotechnology parks, the development of successful compounds and the implementation of efficient manufacturing processes, right up to the establishment of advanced delivery routes.
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Mucosal Delivery of Biopharmaceuticals

Recent years have seen the rise of biopharmaceuticals as promising tools in the
treatment, prophylaxis and diagnosis of multiple diseases. With more than 300
molecules approved worldwide (while others are on late stages of development)
 ...

Author: José das Neves

Publisher: Springer Science & Business Media

ISBN: 9781461495246

Category: Medical

Page: 601

View: 693

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Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals.​ Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.
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Chitosan Based Systems for Biopharmaceuticals

Enormous advances have been made in the field of drug delivery in recent years
parallel with the development of increasing numbers of biopharmaceuticals. The
term “biopharmaceutical” was first used in the 1980s and came to describe a ...

Author: Bruno Sarmento

Publisher: John Wiley & Sons

ISBN: 9781119964070

Category: Science

Page: 600

View: 917

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Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules - making it a valuable component in the formulation of biopharmaceutical drugs. Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceutical use. Finally, Part IV presents diverse viewpoints on different issues such as regulatory, manufacturing and toxicological requirements of chitosan and its derivatives related to the development of biopharmaceutical products, as well as their patent status, and clinical application and potential. Topics covered include: chemical and technological advances in chitins and chitosans useful for the formulation of biopharmaceuticals physical properties of chitosan and derivatives in sol and gel states absorption promotion properties of chitosan and derivatives biocompatibility and biodegradation of chitosan and derivatives biological and pharmacological activity of chitosan and derivatives biological, chemical and physical compatibility of chitosan and biopharmaceuticals approaches for functional modification or crosslinking of chitosan use of chitosan and derivatives in conventional biopharmaceutical dosage forms manufacture techniques of chitosan-based microparticles and nanoparticles for biopharmaceuticals chitosan and derivatives for biopharmaceutical use: mucoadhesive properties chitosan-based systems for mucosal delivery of biopharmaceuticals chitosan-based delivery systems for mucosal vaccination chitosan-based nanoparticulates for oral delivery of biopharmaceuticals chitosan-based systems for ocular delivery of biopharmaceuticals chemical modification of chitosan for delivery of DNA and siRNA target-specific chitosan-based nanoparticle systems for nucleic acid delivery functional PEGylated chitosan systems for biopharmaceuticals stimuli-sensitive chitosan-based systems for biopharmaceuticals chitosan copolymers for biopharmaceuticals application of chitosan for anti-cancer biopharmaceutical delivery chitosan-based biopharmaceuticals scaffolds in tissue engineering and regenerative medicine wound healing properties of chitosan and its use in wound dressing biopharmaceuticals toxicological properties of chitosan and derivatives for biopharmaceutical applications regulatory status of chitosan and derivatives patentability and intellectual property issues quality control and good manufacturing practice preclinical and clinical use of chitosan and derivatives for biopharmaceuticals Chitosan-Based Systems for Biopharmaceuticals is an important compendium of fundamental concepts, practical tools and applications of chitosan-based biopharmaceuticals for researchers in academia and industry working in drug formulation and delivery, biopharmaceuticals, medicinal chemistry, pharmacy, bioengineering and new materials development.
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Preclinical Safety Evaluation of Biopharmaceuticals

of biopharmaceutical and available information on the class of biopharmaceutical
tested. Mere are some differences in pre-clinical studies required for phases 2
and 3 of clinical trials and registration between biopharmaceuticals and NCEs.

Author: Joy A. Cavagnaro

Publisher: John Wiley & Sons

ISBN: 9781118679388

Category: Medical

Page: 1064

View: 635

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"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.
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Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Since the 1980s, the biopharmaceutical industry has been a rapidly growing and
evolving enterprise producing new and more effective biopharmaceuticals. While
most biopharmaceuticals (both in development and as commercial products) ...

Author: Damian J. Houde

Publisher: Newnes

ISBN: 9780444595904

Category: Science

Page: 426

View: 130

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure this book takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.
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Biotechnology and Biopharmaceuticals

Transforming Proteins and Genes into Drugs Rodney J. Y. Ho, Milo Gibaldi.
Appendix V OTHER INFORMATION TABLES Biotechnology and
Biopharmaceuticals, by Rodney J. Y. Ho and Milo Gibaldi ISBN 0-471-20690-3
Copyright © 2003 by ...

Author: Rodney J. Y. Ho

Publisher: John Wiley & Sons

ISBN: 0471450278

Category: Science

Page: 576

View: 747

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Detection and Quantification of Antibodies to Biopharmaceuticals

Recombinant biopharmaceuticals represent an important class of therapeutic
agents, as reflected by sales of some $92 billion in 2009 [1]. The safety and
efficacy of recombinant biopharmaceuticals can be severely impaired, however,
by their ...

Author: Michael G. Tovey

Publisher: John Wiley & Sons

ISBN: 9781118075678

Category: Medical

Page: 432

View: 716

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The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.
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Process Validation in Manufacturing of Biopharmaceuticals

ANALYTICAL TESTING AND CONTROL STRATEGIES Analytical testing is one
of the most important programs in the biopharmaceutical industry. It starts with
raw materials and systems testing and continues through production, purification,
 ...

Author: Gail Sofer

Publisher: CRC Press

ISBN: 9781420001655

Category: Science

Page: 402

View: 630

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A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.
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