One of the most common points of confusion for researchers transitioning from discovery to development is the distinction between Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP). While both represent quality frameworks, they apply to fundamentally different activities and have very different regulatory implications.
GLP is a quality system for non-clinical laboratory studies — primarily toxicology and pharmacology studies intended to support regulatory submissions. It governs how studies are designed, conducted, documented, and archived, ensuring the integrity and traceability of data submitted to health authorities. GLP does not govern the synthesis of compounds used in studies, only the conduct of the studies themselves.
cGMP (more precisely, current Good Manufacturing Practice as defined by ICH Q7 for active pharmaceutical ingredients) governs the manufacturing of compounds intended for use in clinical trials or commercial products. It requires validated processes, qualified equipment, trained personnel, controlled environments, full batch traceability, release testing, and comprehensive documentation.
For peptide synthesis specifically, the transition point from research-grade to cGMP is typically defined by IND-enabling status. Compounds used in formal GLP toxicology studies to support an IND submission should be manufactured under conditions approaching cGMP, even if not fully GMP, to ensure the material used in safety studies is representative of future clinical material.
A pragmatic framework used by many companies is to apply GMP-like controls (identity testing, purity testing, controlled synthesis conditions, batch records) for GLP tox studies, then achieve full ICH Q7 cGMP compliance for Phase I clinical material. This approach balances cost efficiency with regulatory defensibility.
SynthAxis operates both research-grade and fully cGMP-certified synthesis suites, enabling clients to scale from initial feasibility synthesis through GLP tox supply and into full cGMP clinical production within a single CDMO relationship — avoiding the costly and time-consuming tech transfer between suppliers that often delays development timelines.