Transitioning from lab bench to GMP: What research scientists should know about manual aseptic filling - Pharmaceutical Technology

When it’s time to look for a fill-finish CDMO, the transition to GMP filling is not just a scale issue — it’s a regulatory, technical, and operational shift. When it’s time to look for a fill-finish CDMO, the transition to GMP filling is not just a scale issue — it’s a regulatory, technical, and operational shift. Many breakthrough therapies originate in research labs: academic institutions, biotech startups, and translational centers. The research-grade environments in which these early batches are often prepared are not designed for GMP compliance. When it’s time to look for a fill-finish CDMO, the transition to GMP…

Source: Pharmaceutical Technology