Stability of protein pharmaceuticals: an update

Area of Science:

• Biopharmaceutical Sciences
• Protein Chemistry
• Formulation Science

Background:

• Recombinant protein therapy has evolved significantly since 1989.
• A foundational review on protein stability by Manning et al. (1989) remains highly cited.
• Understanding and mitigating protein instability is crucial for therapeutic efficacy.

Purpose of the Study:

• To summarize key advancements in protein stabilization and formulation over the past decades.
• To provide an updated overview of chemical and physical instability in proteins.
• To discuss strategies for enhancing protein stability in various conditions.

Main Methods:

• Literature review of scientific publications on protein stability and formulation.
• Synthesis of current knowledge on protein degradation pathways.
• Analysis of different stabilization techniques and their applications.

Main Results:

• Significant progress has been made in understanding and addressing protein instability.
• Effective strategies for stabilization in both aqueous solutions and the dried state have been developed.
• Chemical modification and mutagenesis offer viable approaches to improve protein stability.

Conclusions:

• Protein stabilization and formulation have advanced considerably, supporting the growth of protein-based therapeutics.
• A comprehensive understanding of instability mechanisms is essential for successful drug development.
• Continued research in this area is vital for optimizing the delivery and efficacy of protein drugs.