LaunchWorks CDMO
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Product Sensitivity Testing Services

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LaunchWorks will establish baseline product performance and sensitivity parameters to create component specific guard bands, which allow for early detection and prevention of performance issues during manufacturing. Additionally, this service establishes the QC acceptance criteria for a product. This allows for a customer to build a component or entire kit, trend data points such as pH, conductivity, enzyme activity, etc, and track historically those criteria that are truly important to the function of the product. Guard-banding critical components allows the customer, and the CMO, to establish the process limits. The workflow for making 2 kits is vastly different than the workflow to make 200 or 2000 kits. These differences can affect a products performance and stability if not properly vetted prior to production onboarding. This also allows for sensitive and/or critical components to be called out in granular detail to ensure no mishandling.