Control Strategies for Synthetic Therapeutic Peptide APIs Part II-Raw Material Considerations

The second part of a three-part series on synthetic peptide is presented. The US Pharmacopeia Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptide. APIs based on currently available regulatory guidance and expectations. A special focus of this art...

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Bibliographic Details
Published in:Pharmaceutical Technology 2014-04, Vol.38 (4), p.48
Main Authors: Eggen, Ivo, Gregg, Brian, Rode, Harold, Swietlow, Aleksander, Verlander, Michael, Szajek, Anita
Format: Magazinearticle
Language:English
Subjects:
Amino acids
Chemical synthesis
Manufacturers
Manufacturing
Peptides
Pharmaceuticals
Raw materials
Reagents
Regulatory agencies
Risk assessment
Series & special reports
Solvents
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Summary:The second part of a three-part series on synthetic peptide is presented. The US Pharmacopeia Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptide. APIs based on currently available regulatory guidance and expectations. A special focus of this article will be on protected amino acid derivatives, setting their specifications and the types of quality control tests necessary to ensure consistent quality of the final API. The term "raw materials" encompasses the starting materials, reagents, and solvents used in the manufacture of an API. Based on the risk assessment, a control strategy must be established that identifies the process steps that can impact the critical quality attributes of the final API. The ability of the manufacturing process to control impurities originating from the starting materials determines their purity requirements. Therefore, strict control of the quality of raw materials, especially critical raw materials, together with appropriate in-process controls, is necessary, to ensure consistency in the quality of the final API.
ISSN:1543-2521
2150-7376