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Did you know……...In addition to the development and technical services provided by Lyophilization Technology, Inc. (LTI) for the past 30 years, we also have a very strong presence in providing aseptic fill/finish capabilities for lyophilized and liquid clinical trial materials. This range of services is helping our clients develop new treatments to the benefit of patients.
The Clinical Trial Materials we produce are of the highest quality and purity. Our Clinical Manufacturing Area (CMA) is fully cGMP compliant, meeting US and EU requirements. We have implemented procedures to minimize production losses and maximize yield, critical when producing small batches with valuable drug substance (DS). The operation has been inspected and approved to handle BSL-2 materials and qualified for high-level containment as well as aseptic processing. Stringent environmental controls within our facility assure a superior level of quality and purity of finished products.
In the period from January 2006 when the first three successful Aseptic Process Simulations were conducted at LTI, until the end of 2022 a total of 322 batches of clinical supplies have been prepared. Batch sizes have ranged from 136 vials for use under a compassionate IND to as large as over 6,000 vials with a range of vial sizes from 2 to 100 cc, and now dual chamber cartridges and syringes.
Our capabilities include:
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Pre-clinical through Phase II Clinical Materials, lyophilized and liquid product presentations.
- Dedicated/disposable product contact items/equipment for the highest level of quality and purity for each product.
- Containment capabilities for handling cytotoxic/highly potent DS including biologics and oncology products.
- Processing following Good Manufacturing Procedures as published in the Code of Federal Regulations, 21 CFR, Parts 210, 211, 600, and 820.
- Lyophilizers ranging from 8 ft² to 48 ft² (0.7 m² to 4.4 m²)
- Batch sizes up to 75 L (Aqueous/Organic Solvents)
- ControLyo™, Nucleation On Demand.
- DEA Registration to handle Controlled Substances.
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