Biologics is Doubling Down in Pennsylvania
Charles River is pleased to announce the acquisition of a new facility in Wayne, Pennsylvania to support the characterization and release of biologics. Along with testing laboratories, the new facility, known as Devon Park, will also have suites for the performance of viral clearance studies. The facility will more than double the laboratory space available at our current facilities in Malvern and King of Prussia, PA and is conveniently located only 8 miles from the current Malvern site. CGMP manufacturing will remain in Malvern, where the clean room facilities are currently being expanded to support an increase in cell and viral banking capacity based on a recent surge in demand for these services.
Moving quality control and viral clearance functions to the larger Devon Park facility offers many advantages to our clients. The increased capacity will not only improve timelines but will also provide opportunities to expand capabilities and enhance material flow and efficiencies. In addition, the consolidation of testing and viral clearance activities at one site reduces the need for clients to conduct multiple quality audits.
We have dedicated a team of people at Charles River to overseeing the transition from our current Malvern and King of Prussia locations to the new facility. They began preparatory activities in November and, along with our group of scientists, are carefully considering the design and allocation of laboratory space along with planning the transfer of equipment and protocols. The formal transfer of assays will be done in phases and during this time the Malvern and King of Prussia facilities will remain fully operational to ensure there are no interruptions to services. CGMP testing in the new Devon Park facility is expected to commence during the summer of 2018. In January, our team began reaching out to clients currently working with the Malvern and King of Prussia facilities to discuss the new laboratories and ensure the planned transfer of services has no impact on their timelines or commitments.
If you have any questions about the facility or would like to inquire about services available for your particular product, please contact us at [email protected].