Therapeutic protein drug products: Practical approaches to formulation in the laboratory, manufacturing, and the clinic (Woodhead Publishing Series in Biomedicine)

0.0

This book provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and ending with administration in the clinic. The contributors describe many commercial therapeutic drug products with the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches as well as a brief section on biophysical and analytical analysis. This section focuses on properties of therapeutic protein formulations such as opalescence, phase separation, color, and subvisible particles. It emphasizes material and process testing to ensure success during manufacturing. Chapters cover the drug product manufacturing process, which includes the process of compounding to filling and address methods of delivery in the clinic and delivery strategies. The book ends with a perspective on the regulatory requirements for therapeutic protein formulations.- Provides a list and description of commercially available therapeutic drug products and their formulations