Quality, Phase-Appropriate GMP Production
Because Asymchem has partnered on hundreds of clinical phase programs at all stages of the drug development pipeline, our manufacturing support of clinical development comes with distinct objectives and challenges. Perhaps most critical is our understanding of which approaches prove most efficient at each stage of the drug development while ensuring appropriate quality and compliance. By partnering with both large pharma and biotech companies, we’ve established robust manufacturing processes for registered starting materials (RSMs), advanced intermediates, and active pharmaceutical substances (API’s) across a diverse set of indications in support of clinical programs. And we know exactly what’s needed to support early clinical (phase 1/2a) and late clinical (phase 2b/3) programs.
Efficient program approaches to manufacture candidates for pre-clinical and phase 1 clinical studies with supporting capabilities, such as a dedicated rapid development and scale-up group and separations group.
Comprehensive services to support progression of candidates through each phase of clinical manufactureo Phase-appropriate process development/analyticalo Process qualification/validationo Supply chain developmento Quality complianceo Regulatory support
Extensive network of suppliers capable of supporting increasing demand as a candidate progresses through the clinical pipeline.
Multiple cGMP manufacturing sites able to support manufacture at a wide range of scales from grams to metric tons.
Core project management structure that will follow a program as it matures to ensure continuity and direction.