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Budget, capacity, and strict regulatory requirements are just some of the hurdles that can prevent the next big breakthrough from commercialization. Less than 1% of all drug candidates entering clinical trials reach the market, which means you need a partner with a proven track record of success.
Explore our Biologics Testing Solutions
With over 40,000 tests run annually at our global biologics testing facilities and 200+ products supported; our team can provide comprehensive testing services for a wide range of modalities. These include monoclonal antibodies/recombinant proteins, viral vectors, vaccines, and cell therapies. Count on us to ensure your biologic is safe, effective, and able to pass regulatory scrutiny.
Are you confident your viral clearance studies fully evaluate the risk for viral contamination in your drug manufacturing process? With over 30 years of experience designing and performing viral clearance projects, we can provide you with intelligent, tailored study designs and timely reports. The end result is a successful, cost-effective program to meet the unique needs of your biopharmaceutical product.
Proper cell line characterization assays are crucial to confirm the certainty of contaminant-free cell banks. Extensive cell line authentication, including phenotypic or genotypic identity testing, is required for mammalian, microbial, and insect cell substrates testing when working to generate biopharmaceuticals.
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