Introduction Engaging specialized GMP Release and Stability Testing Services at a CDMO enables biopharmaceutical developers to access validated analytical testing, […]
1. Introduction Solid-state characterization and polymorph screening are essential components of pharmaceutical development because the physical form of an active
Introduction: Peptide Identity and Purity Testing is essential for determining whether a compounded or research-grade peptide is the correct molecule
How Can You Verify the Identity and Purity of Compounded or Research-Grade Peptides? Read More »
Introduction: Peptide Acylation Impurity Analysis is the targeted detection, identification and, where possible, quantitation of peptide variants carrying unwanted acyl
Introduction Under the FDA’s Draft Guidance on Comparative Efficacy Studies, prospective biosimilar applicants may be able to avoid routine Phase
Introduction Under Section 351(k) of the Public Health Service (PHS) Act, the U.S. Food and Drug Administration (FDA) defines a
Introduction On March 9, 2026, the U.S. Food and Drug Administration (FDA) officially announced the withdrawal of its 2015 biosimilarity
Introduction: Oligonucleotide CDMO Services give drug developers a single, analytically grounded route from sequence design to GMP drug substance, and
Introduction Statistical Approaches to Analytical Similarity encompass quantitative, risk-based frameworks used by regulatory authorities and biopharmaceutical developers to establish that
Introduction Residual uncertainty in biosimilar development determines the scope of regulatory clinical trials by requiring each successive stage of testing
