Charles River Laboratories Makes Expansions to Global Biologics Infrastructure
Published: Mar 08, 2018
- 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.” –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.” –Jim Gombold, Senior Director of Global Technical Services at Charles River
Caution Concerning Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “intend,” “will,” “may,” “estimate,” “plan,” “outlook,” and “project,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward looking statements include statements in this press release regarding future demand for drug discovery and development products and services, the timing of the move of certain laboratory operations to Charles River’s Devon Park site, the on-going enhancements and expansions to our Malvern, Shrewsbury, Erkrath, and Ballina sites, as well as the overall impact of these changes on the Biologics Testing Solutions business. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River's Annual Report on Form 10-K as filed on February 13, 2018, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.
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.
Source: Charles River Laboratories International, Inc.