Charles River Laboratories has made several key expansions to its global Biologics Testing Solutions infrastructure to support the characterization, development, and release of biologics and biosimilars.
 
To increase capacity Charles River recently added a new, 73,000 sq.-ft. facility in Wayne, PA, more than doubling lab space at the company’s existing facilities in Malvern and King of Prussia, PA.
 
Certain lab operations conducted at Charles River’s Malvern and King of Prussia sites will begin to move to Devon Park early in 3Q18. The formal transfer of assays will be done in phases, and during the transition, both the Malvern and King of Prussia facilities will remain fully operational to ensure there will be no interruption of services.
 
In Malvern, PA, 2,800 sq.-ft. of new, state-of-the-art clean rooms dedicated to GMP microbial and mammalian cell banking are being added, increasing cell banking capacity by 40 percent. The company is also upgrading rooms for virus and vaccine production, and, added capabilities for high-volume and high-density cell banks as alternatives to traditional cell bank formats.  
 
In Shrewsbury, MA, the company’s Analytical Center of Excellence (CoE), Charles River is combining and expanding the services offered in Malvern and Woburn, MA under one roof for faster method development and increased offerings. The CoE will also facilitate the continued expansion of analytical and protein characterization services.
In Erkrath, Germany, 4,500 sq.-ft. of new lab space will be designed to meet the special requirements of bioactivity testing, expanding 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.
 
Also, in Ballina, Ireland, additional assays have been introduced, including in vitro adventitious agent and mycoplasma testing, along with the full suite of in vivobiosafety testing methods. A new analytical lab has been opened, offering a portfolio of GMP assays for release testing, short- and long-term stability testing, and comparability testing for biosimilars.  
 
“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.