This item is in: Biomedicine > Pharmaceutical science/technology, drug delivery

Therapeutic protein drug products: Practical approaches to formulation in the laboratory, manufacturing, and the clinic

Edited by B K Meyer, Merck Research Laboratories (MRL), USA

Woodhead Publishing Series in Biomedicine No. 8

 - 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
 - recommendations are made as to how therapeutic proteins can be evaluated at the pilot scale prior to manufacturing, with an emphasis on material and process compatibility testing. The book provides a regulatory perspective on therapeutic protein formulation, specifically topics related to subvisible particles.

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.

ISBN 1 907568 18 2
ISBN-13: 978 1 907568 18 3
January 2012
200 pages  234 x 156mm  hardback  
£110.00 / US$185.00 / €130.00

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About the editor

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.

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Contents

Commercial therapeutic protein drug products
Brian K. Meyer and Mohammed Shameem
 - Introduction
 - Lyophilized formulations
 - Liquid formulations
 - Protein formulations for radiologic and diagnostic use
 - Summary
 - References

A formulation method to improve the physical stability of macromolecular-based drug products
Akhilesh Bhambhani, Santosh Thakkar, Sangeeta B. Joshi and C. Russell Middaugh
 - Introduction
 - Common techniques used for the construction of EPDs
 - The peptide drug pramlintide
 - Monoclonal antibodies at low and high concentration
 - Static vs. dynamic EPDs: a case study using a humanized immunoglobulin (IgG1)
 - Conclusion and future studies
 - References

Properties of protein formulations
Henryk Mach, Brian K. Meyer and Mohammed Shameem
 - Introduction
 - Opalescence
 - Phase separation
 - Color
 - Subvisible particles
 - References

Material and process compatibility testing
Brian K. Meyer
 - Introduction
 - Material compatibility
 - Process compatibility testing
 - Antimicrobial preservative compatibility testing
 - References

Compounding and filling: drug substance to drug product
Brian K. Meyer and Louis Coless
 - Introduction
 - Aseptic processing
 - Bulk drug substance
 - Compounding of drug product
 - Filling the drug product
 - References

Administration in the clinic
Manoj Sharma, Chakravarthy Narasimhan and Mohammed Shameem
 - Introduction and background
 - Diluents
 - Components
 - Construction materials
 - Clinical dosing strategy: fixed volume versus fixed concentration
 - Representative admixture concentration levels
 - Exposure temperature and time
 - Option of using syringes
 - Analytical tests and acceptance criteria
 - Sample preparation considerations
 - Role of probe studies
 - Bag overfill volume
 - Pharmacy instructions
 - Conclusions
 - Notes
 - References

Regulatory guidelines for the development of a biotechnology drug product
Mark J. Waskiewicz
 - Introduction
 - ICH overview
 - Common Technical Document (CTD)
 - Drug product dossier
 - Regulatory considerations through the biotechnology
 - product lifecycle
 - Conclusions
 - Notes

Appendix

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