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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.

This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

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.

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.

This book describes methods and procedures for preparing PET radiopharmaceuticals, and highlights new methods for conducting radiochemical reactions with carbon-11 (C11) and fluorine-18 (F18), which are two of the most commonly used radionuclides in positron emission tomography (PET) imaging. • Provides reliable methods for radiochemical syntheses and reactions, including all essential information to duplicate the procedure • Eliminates the time-consuming process of searching journal articles and extracting pertinent details from lengthy experimental sections or supporting information • Focuses on an emerging and important area for pharmaceutical and medical applications • Encompasses technical, regulatory, and application aspects • Includes solid-phase radiochemistry, transition-metal catalyzed radiochemistry, microfluidics, click chemistry, green radiochemistry and new strategies for radiopharmaceutical quality control