Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
This paper, written by Drs. John Wang and Musetta Hanson, is a review of concerns in formulating injectable products containing peptides and proteins. It covers degradation and experimental methods to study denaturation, and evaluates stabilizers and the use of stabilizing excipients.
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Table of Contents:
II. Degradation of
Proteins and Peptides
III. Experimental Methods to Study Denaturation and
IV. Use of Excipients to Stabilize Parenteral
Formulations of Proteins and Peptides
V. Special Considerations