Aseptic Filling and Freeze Drying
Aseptic filling and lyophilization for clinical supply. Two dedicated lines handle liquid fill and freeze-dried presentations under full cGMP, with cycle development, container closure integrity testing and release support delivered by the same team that developed your formulation.
概述
赞助商在评估生物制剂CMC外包合作伙伴时需要了解的一切——从产能到合规性。
Our team provides the entire drug product manufacturing chain comprising liquid fill & finish and lyophilization. We offer final drug product formulation, fill & finish and lyophilization services compliant with cGMP conditions. Aseptic filling of sterile liquid drug products is available up to 1800 vial/hr in the range of 2mL-20mL glass vials – utilizing an automatic vial washing, depyrogenation, filling with 100% online weighting system, stoppering & capping production line in class B+A environment. Up to 5000 units can be provided for 2-20mL glass vials lyophilization.
