Lyophilization Technology

Clinical Manufacturing

Carrie Shults"We are focused on making sterile clinical material to meet a deadline, but even more so, on doing the right thing and doing it well. From patient population and route of administration to fill volume and cycle parameters, all the details, big and small matter. We are providing hope for clinical and future patients."
- Carrie A. Shults, Associate Director, Clinical Manufacturing

Flexibility in Clinical Supply Manufacturing

Lyophilization Technology, Inc. has experience with a wide variety of products, from vaccines to IV therapy presentations. We provide aseptic filling of preclinical and clinical (Phase I and II) materials. The Clinical Trial Materials we produce are of the highest quality and purity, meeting US and EU requirements. Our Clinical Manufacturing Area (CMA) is fully cGMP compliant. We are able to capitalize on our distinct flexibility to meet or exceed your expectations while adhering to aggressive project timelines. We have developed procedures to minimize production losses and maximize yield which is critical when producing small batches with valuable API.

Clinical Supply ManufacturingOur CMA includes separate controlled areas for warehousing, preparing materials, compounding, filling, and inspecting. The operation has been inspected and approved to handle BSL-2 materials and qualified for containment and aseptic processing. Stringent environmental controls within our facility allow for a superior level of purity in your finished product.

When you're ready to take advantage of our expertise and flexibility, contact us so we can schedule your onsite GMP audit.


  • Clinical trial manufacturing
      Phase I
      Phase II
  • Toxicology Material Processing
  • Aseptic vial filling
  • Aseptic cartridge filling
  • Small-batch manufacturing
  • Specialized, flexible capabilities
  • ControLyo™, Nucleation On Demand

Click here for a full list of clinical manufacturing capabilities >