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Protein and Peptide Therapeutics: Stability Challenges, Regulatory Demands, and Innovative Formulation Solutions for
Megha Patel1, Dhruv Parikh2, Akshay Parihar3
1Gujarat Technological University, School of Pharmacy, Gandhinagar 382028, Gujarat, India.
Protein and Peptide Letters
|July 15, 2025
Summary
Protein and peptide therapeutics face challenges like rapid clearance and degradation. Enhancing their stability through advanced techniques and regulatory compliance is key to developing safe and effective treatments.
Area of Science:
- Biochemistry and Pharmaceutical Sciences
- Drug Development and Delivery
Background:
- Proteins and peptides are vital in biology and medicine but limited by rapid renal clearance and enzymatic degradation.
- Peptides offer targeted delivery and improved patient adherence due to their structured amino acid sequences.
- Proteins exhibit complex stability influenced by pH and environmental factors, necessitating specialized formulation.
Purpose of the Study:
- To explore challenges in protein and peptide therapeutic development.
- To highlight the importance of stability and regulatory compliance.
- To present strategies for enhancing the stability of protein and peptide therapeutics.
Main Methods:
- Review of current literature on protein and peptide stability.
- Analysis of regulatory guidelines (FDA, EMA, PMDA) such as ICH Q5C and ICH Q1A(R2).
- Exploration of innovative stability enhancement techniques including protein engineering, lyoprotection, and nanoparticle encapsulation.
Main Results:
- Identification of renal clearance and enzymatic degradation as primary limitations.
- Emphasis on the critical role of formulation optimization, temperature control, and aggregation mitigation.
- Demonstration of various techniques to improve therapeutic stability and longevity.
Conclusions:
- Overcoming stability and degradation issues is crucial for effective protein and peptide therapeutics.
- Adherence to stringent regulatory standards ensures safety and efficacy.
- Integration of scientific innovation with regulatory compliance facilitates the development of advanced biologic drugs.
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