Lyophilization Technology

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.

Our 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.

"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
Amy M. Bosch

Clinical Manufacturing Services

Clinical Trial Manufacturing

LTI 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.

Toxicology Material Processing

While Toxicology material is used to assess the safety of a drug or compound, typically in preclinical studies involving animal models, LTI processes toxicology material to the same high level of quality and control expected from clinical trial material.

Aseptic Vial Filling

Qualified equipment is utilized to process 2R through 50R vials.

Aseptic Compounding

Aseptic compounding of drug substances and intermediates in primary packaging components or bulk trays.

Small-batch Manufacturing

From a small batch size with <1L of bulk solution up to 75L, we have developed procedures to minimize production losses and maximize yield which is critical when producing small batches with valuable API.

Specialized, Flexible Capabilities

We are able to capitalize on our distinct flexibility to meet or exceed your expectations while adhering to aggressive project timelines.

ControLyo™, Nucleation On Demand

Controlled nucleation on demand, often referred to as ControLyo™ technology, is a method used in the freeze-drying process to precisely control the nucleation (formation of ice crystals) of a product solution. This technology involves pressurizing the freeze dryer chamber with an inert gas, such as nitrogen or argon, to a specific pressure. At a predetermined temperature, the pressure is rapidly released, causing simultaneous nucleation throughout the product. This controlled approach offers several benefits including batch uniformity, consistent product quality, and often a reduced processing time.

Let's discuss how LTI can help with your next project!

Lyophilization in Clinical Trial Material Preparation

Quality Assurance (QA) is vital for maintaining the integrity, safety, and efficiency of clinical trial material production, ultimately leading to more reliable and trustworthy outcomes.

Quality assurance (QA) is crucial in the production of clinical trial material for several reasons:

  • Ensuring Data Integrity: QA processes help ensure that the data collected during manufacturing is accurate, reliable, and consistent.
  • Regulatory Compliance: Clinical trial material produced by aseptic processing must adhere to various regulations and guidelines. QA ensures that all aspects of the manufacturing meet these requirements, which is necessary for acceptance by global regulatory agencies.
  • Efficiency and Cost-Effectiveness: By identifying and addressing potential issues early, QA can improve the efficiency of clinical trial material production, reduce costs, and accelerate the development of new treatments.
  • Building Trust: High-quality assurance practices build confidence and trust in not only the client but also the regulatory bodies reviewing the submission.
OUR QUALITY SYSTEM