PCI Pharma Services expands its temperature-controlled facilities
Rockford, IL, site will get dedicated refrigerated packaging capacity
Targeting ATMPs--advanced therapeutic medicinal products (aka cellular and genetic therapies)—PCI Pharma Services has broken ground on an expansion of its Rockford, IL campus. The 30,000-sq. ft. expansion includes a dedicated 2-8°C packaging suite, as well as storage for controlled room-temperature, refrigerated, and cryogenic products. It is expected to go online in late 2019, following fit-out, validation and licensing.
“We are extremely excited to see the initial construction begin on our Clinical facility expansion at the Rockford site,” said Brian Keesee, VP and GM. “We are also seeing more focus on specialized medicines with special handling requirements. Particularly with the market growth in Biologics and Biosimilars, the need for temperature-controlled therapies continues to increase. The new suites will allow us to provide faster turnaround times and increased flexibility.”
PCI Pharma Services provides contract services for projects ranging from Phase I clinical trials to commercial packaging, from facilities in the US, Europe and Australia.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
