Analytical Development

cGMP Stability

AGC Biologics’ comprehensive suite of analytical and bioassay development services enable us to provide our clients with validation data and full documentation to meet all cGMP, ICH and international regulatory authority requirements.

We conduct stability studies to determine shelf life for active pharmaceutical ingredient (API), intermediates, drug product, placebo and reference standards. In addition, we can design stability studies to meet your specific requirements.

Our cGMP stability capabilities and assets include:
• Customer reviewed and approved stability protocols
• QC and QA reviewed Certificates of Analysis provided at each time point
• Capacity to support all ICH long term, intermediate and accelerated stability conditions
• 24-hour monitoring of all stability chambers and freezers with emergency backup