Sigma-Aldrich Corporation has announced that SAFC® Commercial (www.sigma-aldrich.com/safc), the business unit providing products and services for use in regulated pharmaceutical and biopharmaceutical applications, has validated its recently expanded facility in Irvine, Scotland, which now features dry powder cell culture media.
The Irvine expansion, announced in March 2013, was initiated as part of a five-year capital investment plan designed to support SAFC customers with critical products and services across the globe. Now fully validated, the site acts as the European counterpart to the Lenexa, Kansas, Center of Excellence for cell culture media manufacture and supply in the U.S.
“As the market continues to change, we’ve recommitted to staying flexible and providing exceptional support for customers, which helps reduce their risk and lowers their cost of ownership,” said Gilles Cottier, President of SAFC. “True supply redundancy and the ability to source consistent product supply in different parts of the world are key factors in providing this level of support.”
The dry powder media manufacturing capabilities added to the Irvine site are redundant to the manufacturing processes, technology and materials used at the Lenexa facility to ensure reproducible and comparable high-quality product across both sites. SAFC’s new dry powder milling and blending capabilities in Irvine are animal component-free and complementary to the liquid cell culture media, buffers and reagents that were already featured at the site.
“Irvine is one of the most modern and fit-for-purpose media facilities in the industry. With the expansion complete, SAFC is unique in its ability to support projects from early clinical development through commercial scale using a globally consistent approach across our cell culture media manufacturing sites in Irvine, Scotland; Lenexa, Kansas; and St. Louis, Missouri,” Cottier said.
The site expansion concentrated on creating shorter lead times, improving flexibility and giving customers access to real-time information. Efficiencies in throughput and responsiveness were achieved by decoupling manufacturing processes and focusing on supply logistics, while progressive technologies for in-line monitoring and a process intelligence data historian system deliver transparency. Storage capacity was also expanded, creating new material and finished goods warehousing space.
All construction work completed at the Irvine facility fully complies with appropriate U.S. FDA and EU cGMP requirements, as well as local safety and environmental regulations.