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.
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.
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.
Qualified equipment is utilized to process 2R through 50R vials.
Aseptic compounding of drug substances and intermediates in primary packaging components or bulk trays.
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.
We are able to capitalize on our distinct flexibility to meet or exceed your expectations while adhering to aggressive project timelines.
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!
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: