Medical Device Directory

Clinical Manufacturing: Phase I and Phase II Clinical Material and Toxicology Material in a Containm

Available from Lyophilization Technology, Inc.

Preparation of clinical materials in this expanded facility complement the extensive activities currently performed in the conventional development laboratory and pilot plant. Batch preparation, aseptic processing and lyophilization are completed in a unique aseptic fill/finish facility with isolation and containment capabilities using disposable and dedicated equipment. This area allows processing of BSL-2 biologicals, controlled substances, highly potent compounds and oncolytics. Stringent environmental controls within this unique facility allow for a superior level of purity in the finished product.

Clinical Manufacturing Area (CMA) is flexible for preparation of products with unique requirements, adheres to aggressive project timelines, and is fully cGMP compliant. The dedicated CMA includes separate controlled areas for warehousing, preparing materials, compounding, fill / finish, inspection, and packaging. The aseptic processing suite features HEPA unidirectional air supply and returns, containment, and isolation technology. The operation has been inspected and approved for handling BSL-2 material and qualified for containment and aseptic processing.

Experience with a variety of products, from vaccines to IV therapy presentations, capitalizes on our unique flexibility in preparation of parenteral products. Clinical Trial Material, with control for high yield and minimal loss, is of the highest quality and purity, meeting US and EU requirements.

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