To increase its capacity and support higher demand, Charles River recently added a new, 73,000 square-foot facility on
Certain laboratory operations conducted at Charles River’s
Additional Capacity and Capability Enhancements
Malvern, Pennsylvania: 2,800 square feet of new, state-of-the-art clean rooms dedicated to GMP microbial and mammalian cell banking are being added to this facility. The enhancement will increase cell banking capacity at Malvernby 40 percent, as well as upgrade rooms for virus and vaccine production. The Company has also added capabilities for high-volume and high-density cell banks as alternatives to traditional cell bank formats. The new manufacturing space is expected to be validated and operational by May 2018. Shrewsbury, Massachusetts: Shrewsburyhas been designated as the Company’s Analytical Center of Excellence (CoE). The CoE leverages current analytical capabilities already in place in Shrewsbury, along with key capabilities offered in Malvernand Woburn, Massachusetts. Combining and expanding the services offered by these three locations under one roof allows for faster method development, increased offerings, and stronger collaborations with clients. The CoE will also facilitate the continued expansion of analytical and protein characterization services.
Germany: 4,500 square feet of new laboratory space designed to meet the special requirements of bioactivity testing are being added to this facility. In the new laboratory, Charles River will expand its offerings for the development, transfer, and optimization of bioassay methods, including support for lot release, stability testing, accelerated stress condition testing, and the comparability testing of biosimilar products.
Ireland: Additional assays have been introduced, including in vitro adventitious agent and mycoplasma testing, along with the full suite of in vivo biosafety testing methods. A new analytical laboratory has been opened, offering a portfolio of GMP assays for release testing, short- and long-term stability testing, and comparability testing for biosimilars. The addition of capabilities for water testing is planned for later in 2018.
- “The high volume of biologics and biosimilars in development has led to a rapid increase in demand for our services. The continued expansion of our Biologics service portfolio and additional capacity will further enhance our ability to support clients’ development efforts from discovery through clinical phases and commercial manufacturing.” –Greg Beattie, Corporate Vice President, Global Biologics Testing Solutions at Charles River
- “The increased capacity offered at
Devon Parkwill improve timelines for our clients, provide opportunities to expand capabilities, and enhance material flow and efficiencies. The consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits.” –Jim Gombold, Senior Director of Global Technical Services at Charles River