Introduction An ICH Q3D Elemental Impurity Assessment provides a systematic, science-based safety framework for identifying, quantifying, and controlling toxic elemental […]
Introduction Building an IND-Enabling CMC Analytical Package for a virtual biotech requires establishing a phase-appropriate, regulatory-compliant analytical data package that
Case Study: Building an IND-Enabling CMC Analytical Package for a Virtual Biotech Read More »
Introduction When a drug product is transferred to a new contract facility, executing an Analytical Method Transfer and Re-Validation ensures
Case Study: Analytical Method Transfer and Re-Validation After a Sponsor Changed CDMOs Read More »
Introduction: Can a CDMO manufacture both peptides and biologics? Yes, a Contract Development and Manufacturing Organization (CDMO) can support both,
Can a CDMO Manufacture Both Peptides and Biologics? Read More »
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Introduction Under the FDA’s Draft Guidance on Comparative Efficacy Studies, prospective biosimilar applicants may be able to avoid routine Phase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
