Therapeutic Protein Drug Products book cover

Therapeutic Protein Drug Products

Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic

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 focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also 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 ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

Hardbound, 200 Pages

Published: January 2012

Imprint: Woodhead Publishing

ISBN: 978-1-907568-18-3

Contents

  • Commercial therapeutic protein drug products; A formulation method to improve the physical stability of macromolecular-based drug products; Properties of protein formulations; Material and process compatibility testing; Compounding and filling: Drug substance to drug product; Administration in the clinic; Regulatory guidelines for the development of a biotechnology drug product.

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