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Therapeutic Protein Drug Products: Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic (Woodhead Publishing Series in Biomedicine)

Amazon.com Price:  $133.30 (as of 12/05/2019 16:46 PST- Details)

Description

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focal point on the commonest buffers, excipients, and Ph ranges that are commonly tested along with systematic approaches. A brief section on biophysical and analytical analysis could also be provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to verify success right through manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, could also be covered. Methods of delivery in the clinic are addressed, in addition to delivery strategies. In any case, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

  • Provides a list and description of commercially to be had therapeutic drug products and their formulations
  • A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic
  • Discusses up to date topics including high protein concentration, phase separation, opalescence, and subvisible particles
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