WILMINGTON, MA — Charles River Laboratories International recently announced several key expansions to its global Biologics Testing Solutions infrastructure to support the characterization, development, and release of biologics and biosimilars. Growth in this industry has led to increased demand for outsourced services, providing an opportunity for Charles River to enhance capacity and capabilities in support of client needs.
To increase its capacity and support higher demand, Charles River recently added a new, 73,000 square-foot facility on Devon Park Roadin Wayne, Pennsylvania. This facility will more than double the laboratory space available at Charles River’s existing facilities in Malvern and King of Prussia, Pennsylvania.
Certain laboratory operations conducted at Charles River’s Malvern andKing of Prussia sites will begin to move to Devon Park early in the third quarter of 2018. The formal transfer of assays will be done in phases, and during the transition, both the Malvern and King of Prussiafacilities will remain fully operational to ensure there will be no interruption of services.
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 Malvern by 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: Shrewsbury has 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 Malvern and 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.
- Erkrath, 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.
- Ballina, 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,” said Greg Beattie, Corporate Vice President, Global Biologics Testing Solutions at Charles River
“The increased capacity offered at Devon Park will 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,” added Jim Gombold, Senior Director of Global Technical Services at Charles River
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
(NOTE: The above press release is from the Charles River Labs.)
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