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:

I. Introduction
II. Degradation of Proteins and Peptides
III. Experimental Methods to Study Denaturation and Evaluation Stabilizers
IV. Use of Excipients to Stabilize Parenteral Formulations of Proteins and Peptides
V. Special Considerations
VI. Recommendations
VII. References