A large-scale mammalian cell-culture-based production facility built by MedImmune, a unit of AstraZeneca ($AZN), has been named facility of the year by competition sponsors ISPE, INTERPHEX and Pharmaceutical Processing. The trade group, trade show and magazine highlighted the safety record of the project: The facility was built in 2.3 million man-hours without a lost-time incident, according to a statement.
Among the standout characteristics of the project: military-inspired training techniques to transition the workforce to the new facility. Also, the project team developed "a comprehensive shakedown schedule" to maximize practice runs prior to process validation, the statement says.
In addition, the team developed a simulator for offline commissioning and qualification of the integrated process control system, which freed the actual equipment for shakedown runs. In 13 shakedowns and three process-validation runs, the team experienced no incidents of contamination or lost batches, according to the statement.
The Frederick, MD, plant, used in the production of various product titers, was named overall winner of the 7th annual competition. The award recognizes "state-of-the-art pharmaceutical manufacturing projects" that help reduce the cost of high-quality drug production, according to the statement.
The new plant was built for production of forthcoming products. It is situated adjacent to MedImmune's existing Frederick Manufacturing Center.
- here's the announcement