Stability Testing for Peptide and Protein-Based Drugs: Regulatory and Analytical Best Practices
Stability Testing for Peptide and Protein-Based Drugs: Regulatory and Analytical Best Practices Stability Testing for Peptide and Protein-Based Drugs: Regulatory and Analytical Best Practices Introduction Peptide and protein-based pharmaceuticals—including recombinant proteins, monoclonal antibodies, synthetic peptides, and fusion proteins—are becoming increasingly prevalent due to their high specificity and therapeutic efficacy. However, these biologically derived or synthesized…