Facility manages clinical trial supply, storage, packaging and distribution
A facility that opened only in 2013 in the Shanghai Free Trade Zone is now being quadrupled in capacity by Catalent Pharma Solutions (Somerset, NJ). The cGMP site is also validated to support biologics requiring refrigerated and frozen supply chain management and currently offers 15-25°C controlled room temperature, 2-8°C refrigerated, -20°C frozen and -80°C ultra-low frozen storage environments. The expansion includes dedicated receiving, dispatch and packaging areas.
“In the two years since the facility opened, we have seen a sharp increase in the utilization of the site, with a shift towards more trials involving biologics and temperature sensitive drugs,” commented Wetteny Joseph, Catalent’s President of Clinical Supply Services, in a statement. The Shanghai facility is close to two international airports, and enables Catalent to manage trial supply in the Asia region with expedited customs clearances.
Catalent also announced that it had added further packaging and low-temperature storage capacity to its Singapore facility, citing the need to support secondary packaging and innovative and flexible clinical supply services. “This expansion continues our strategic growth program within the Asia-Pacific region, and follows our announcement in June 2015, that we are increasing capacity at our Singapore clinical supply facility by 60%,” continued Joseph.
Catalent’s clinical trial supply network includes sites in the US, Germany, Singapore and China, along with over 50 audited depots around the globe. The Shanghai expansion is already underway and is expected to be operational by the end of the year