A full-service contract manufacturing organization (CMO) encounters many compounds at different phases of development and varying customer requirements. From fully developed large scale manufacturing to a single development batch, the CMO must be prepared to handle multiple compounds in the same facility.
Aseptic processing in pharmaceuticals is not without its complications, particularly as they relate to reducing patient risk. This white paper discusses an easy-to-use aseptic processing method that is based on real-world risk factors instead of theoretical concepts while emphasizing the impact of a pharmaceutical manufacturer’s personnel.
This article discusses the removal of bacterial endotoxins in a washing process and the need for a continuous monitoring activity according to common cleaning validation practices. Results of washing tests performed with different load materials following an effective cleaning strategy to remove microbiological soil are presented. In addition, this paper compares two different online assay methods: conductivity analysis and Total Organic Carbon analysis.
The Central Fractionation Unit of the Belgian Red Cross (C.A.F.-D.C.F.) headquartered in Brussels supplies the domestic market with plasma proteins and acts as a contract manufacturer.