As part of a continuing program of investment, we’ve added 5 rooms with Biosafety Level (BSL) 2 containment to our preclinical facility in Horsham, PA, which is recognized for its capabilities in cellular therapeutic safety evaluations. Driven by client demand, the redevelopment significantly expands our capabilities for conducting studies using vaccines and stem cells, as well as gene therapy. As a result, clients are already benefiting from improved scheduling of their studies.
Cellular and gene therapy program designs share similar components and characteristics, including being able to simultaneously demonstrate product safety and support clinical trials. Charles River supports the development of cellular and gene therapies via a strategic and consultative-based approach with great consideration given to scientific and regulatory concerns. Designs for both individual studies and complete programs integrate both safety and efficacy aspects as well as mitigate risk factors inherent in developing these types of therapies. The multidisciplinary teams at Charles River can accommodate the novel properties of cellular or gene products, including complications of cross-species reactivity.
We have also effectively supported the vaccine industry for decades with a unique range of products and related services. A global network of scientific, technical and regulatory experts provide vaccine developers with the right expertise early in the development process to boost productivity, efficiency, and profitability and get the safest and most effective vaccines to market.
Our capabilities include vaccine and vector safety studies in multiple species via multiple dose routes, providing the efficacy and safety testing data required for vaccines and other anti-infective agents. We design and perform studies in CDC-approved quarantine facilities with Biosafety Level (BSL)-2 upgrade ratings to fulfill our client’s preclinical regulatory needs in a Good Laboratory Practice (GLP)-compliant environment.