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SPL offers a broad spectrum of technology capabilities in support of development and manufacturing services for the extraction, isolation and purification of naturally-derived materials and fermentation, isolation and recovery of therapeutic proteins. These services range from preclinical and clinical supplies in cGMP compliant suites through commercial scale-up of APIs. Manufacturing services can be carried out in either existing facilities or possibly through leveraging our existing infrastructure via expanded capital additions when required.
Full analytical, validation and regulatory filing support assures that the API manufacturing component of a development project need not be a roadblock on a project's critical path. In collaboration with our customers, successful application of this approach reduces risk, enabling customers to deploy their scarce resources on the things that are most important in getting their products to market. All services operate within cGMP compliant facilities with stellar regulatory records, available upon request.
General Capabilities include:
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