Application of Formulation Principles to Stability Issues Encountered During Processing, Manufacturing, and Storage of Drug Substance and Drug Product Protein Therapeutics

The field of formulation and stabilization of protein therapeutics has become rather extensive. However, most of the focus has been on stabilization of the final drug product. Yet, proteins experience stress and degradation through the manufacturing process, starting with fermentaition. This review describes how formulation principles can be applied to stabilize biopharmaceutical proteins during bioprocessing and manufacturing, considering each unit operation involved in prepration of the drug substance. In addition, the impact of the container on stabilty is discussed as well.(c) 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

Automated summary

The field of formulation and stabilization of protein therapeutics is extensive. This review discusses the application of formulation principles to stabilize biopharmaceutical proteins during bioprocessing and manufacturing, considering each unit operation involved in drug substance preparation. The impact of the container on stability is also addressed.