Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product

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Monoclonal antibodies (MAbs) are the major course of proteins bio therapeutic being produced by biotechnology and pharmaceutical businesses.This book covers downstream processing which include design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. Monoclonal Antibodies discusses the challenges and problems revolving around advancement of a monoclonal antibody made by recombinant DNA technology right into a therapeutic agent. The issues and strategies that may overcome these restrictions are talked about in this book, you start with an introduction to these problems, accompanied by chapters detailing ways of cope with them. The latter is becoming very important because so many indications such as for example arthritis and asthma need the advancement of formulations for subcutaneous delivery (SC). The advancement of formulations for IV delivery can be important and includes a different set of issues. The characterization of the ultimate drug item is covered where in fact the usage of biophysical methods coupled with genetic engineering can be used to understand the answer properties of the formulation. Subsequent chapters explore the digesting and storage space of mAbs, advancement of delivery device systems and conclude with a chapter on the continuing future of mAbs in therapeutic remedies.

• Discusses the challenges to build up MAbs for intravenous (IV) and subcutaneous delivery (SC)
• Presents ways of meet up with the challenges in advancement of MAbs for SC and IV administration
• Discusses the usage of biophysical analytical equipment in conjunction with MAb engineering to comprehend what governs MAb properties at high focus

See also

• Basic Principles of Drug Discovery and Development
• Synthesis of Best-Seller Drugs
• Sterile Products and Aseptic Techniques for the Pharmacy Technician (2nd Edition)