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The paradigm shift during the pandemic now allows us to develop new biologics that were never possible before and find treatments for autoimmune disorders that remain untreatable.

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This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions. The unit processes described include several emerging trends and advice on reducing the costs of the product and efficient scale up techniques. Intended for practitioners in the commercial biopharmaceutical...

The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy.

The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy.

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Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic and biosimilar biological products, from the scientific basis through the marketing issues. This practical book includes comprehensive information on establishing a manufacturing system and securing regulatory approval for biogeneric

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The average cost of an uncomplicated patent application filing is about $10, 000. This high cost can leave thousands of inventors out in the cold. Filing Patents Online: A Professional Guide is a complete manual that walks inventors through each step of filing and prosecuting the patent online at a fraction of the cost. The online filing system recommended in the book allows continuous monitoring of the review status and for a much faster appr...

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products presents practical details involved in complying with the current good manufacturing practic...

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this handbook provides detai...

This comprehensive bioprocessing textbook deals with the basic concepts, definitions, methods, and applications of the use of biological catalysts to deliver products of high value and utility, from alcohol to recombinant monoclonal antibodies to common day use fuel. It covers all modern aspects, including the means of processing that are required for drug processing to the use of biofuels, downstream bioprocessing, bioprocess design, and regu...

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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.