The CMC formulation group has developed robust liquid formulations for numerous biopharmaceutical products.
Candidate formulations are rapidly identified and subjected to real-time and accelerated-stability studies. Analytical methods, developed in parallel, provide information about product stability. CMC Biologics has the ability to develop lyophilized formulations.
Final formulations are selected and can be subjected to stability protocols following ICH guidelines. Container/closure recommendations for drug product are made. The stability of drug product in contact with delivery devices is assessed.