In the third quarter of 2018, some of the company’s Malvern and King of Prussia-based laboratory operations will be transferred to the new Wayne, PA-based facility on Devon Park Road. Assay transfer will be phased, during which time both facilities will remain fully operational, according to the company.
Greg Beattie, corporate vice president, Global Biologics Testing Solutions at Charles River explained that the consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits
Beattie also told us the company anticipates that the addition of the new Devon Park facility will affect employee headcount— “with more laboratory space, we plan to expand to meet increased client demand,” he said.
“There has been a recent surge in the number of biologics and biosimilars in development,” Beattie added. “This increase has led to more and more of our clients looking to outsource all pieces of the biologic development process, from discovery through commercial manufacturing.”
In response to this demand, Charles River has made several other expansions across its global Biologics Testing Solutions infrastructure, including a further 2,800 square feet of new clean rooms added at its Malvern facility.
The clean rooms are dedicated to GMP microbial and mammalian cell banking and increase the site’s capacity by 40%. The space is expected to be validated and operational by May 2018.
The company has also designated its Shrewsbury, MA facility as its Analytical Center of Excellence (CoE), which, according to the company, will facilitate expansion of analytical and protein characterization services.
Additionally, on the other side of the Atlantic, Charles River is expanding its offerings for the development, transfer, and optimization of bioassay methods. The additional 4,500 square feet of new laboratory space in Erkrath, Germany is designed to meet bioactivity testing requirements.
In Ballina, Ireland, the company has introduced additional assays, including in vitro adventitious agent and mycoplasma testing as well as in vivo biosafety testing methods. A new analytical laboratory offers a range of GMP assays for release testing, short- and long-term stability testing, and comparability testing for biosimilars. Water testing capabilities are expected to be added in 2018.