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Clinical Drug Substance Manufacturing

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Drawing upon our vast experience and track record of successful technology transfers, we have developed workflows to accelerate the transfer of your biologics process at any stage of the product life-cycle. With the aid of our tech transfer, risk assessment, and project scoping toolboxes, we streamline the upfront work to maximize the chances of successful operations and regulatory filing. Our on-site process development and optimization support spans the full range of upstream and downstream processes along with complete analytical and QC functions.

By offering multiple clinical manufacturing sites around the globe, we provide a “dual-source” manufacturing network and geographic coverage to provide efficient and cost-effective manufacturing no matter where your clinical trials are taking place. For more information on each of our clinical drug substance manufacturing sites, click on the respective tabs

In addition to our highly vetted fed-batch bioprocessing, the following key solutions flex to meet your long-term strategy and program needs.