Introduction Rescuing a delayed Phase I program depends on replacing fragmented, multi-vendor outsourcing arrangements with a single, integrated Contract Development […]
Introduction: Choosing the right GMP Extractables and Leachables Testing partner is a critical decision for contract development and manufacturing organizations
How CDMOs Should Vet a GMP Extractables and Leachables Testing Partner Read More »
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
