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.
When considering the replacement of a ULT ten years old, or older, there are many variables to consider. New technology solves some of the issues found in older freezers and reflects new trends in Ultra-low Range (ULR) freezer construction.
The new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs.
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.