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 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.

Key Features

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

Readership

The pharmaceutical and biotechnology industries

Table of 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.

Details

No. of pages:
200
Language:
English
Copyright:
© 2012
Published:
Imprint:
Woodhead Publishing
Print ISBN:
9781907568183
Electronic ISBN:
9781908818102

About the editor

Brian Meyer

Dr Brian K. Meyer is a Research Fellow in Bioprocess Research and Development, Merck Research Laboratories (MRL). Dr Meyer's current position is leading a group in Vaccine Drug Product Development. Previously, Dr Meyer's team was responsible for formulating therapeutic proteins in pre-clinical development. Prior to joining MRL, Dr Meyer was a Process Scientist in Vaccine Technology and Engineering, Merck Manufacturing Division. He has a Ph.D. in Biochemistry, Microbiology, and Molecular Biology from The Pennsylvania State University and a B.S.E. in Biomedical Engineering from Tulane University.

Affiliations and Expertise

Merck Research Laboratories (MRL), USA