Lyophilization Technology, Inc.
30 Indian Drive
Ivyland, PA 18974-1431
T: (215) 396-8373
F: (215) 396-8375
WHO WE ARE
Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.
Clients leverage on our abilities for bringing new products to the clinic and implementing improvements for current products. Capitalize on over 25 years of excellence and our unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.
Biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations, along with universities and research institutes have engaged our support in successful collaborations for a variety of projects. These projects span initial product and process development for new entities right out of drug discovery through Phase I/II clinical material, to technology transfer to commercial manufacturing with regulatory approval. Gaining a global reputation, LTI has been sought after and completed projects with clients in the European, Middle East, and Asian Pacific regions, as well as North America.
LTI successfully develops formulations, processes or prepared clinical material for many diverse products, including:
Development Sciences focuses on formulation through finished product characterization. The Process Lab provides capacity for small to medium scale lyophilization. Filtration, filling, stoppering, and loading the qualified pilot-scale lyophilizers are in certified Class A/100 environments, emulating aseptic manufacturing conditions.
US/EU compliant Clinical Manufacturing Area (CMA) for preparation of clinical material enables us to process a wide range of products, including those having unique requirements. The CMA includes an aseptic suite featuring advanced containment/isolation technology using unique disposable negative pressure isolators inspected and approved for handling BSL-2, cytotoxic and highly potent compounds. LTI has also developed the technology that allows us to freeze dry product in both dual chamber cartridges and pre-filled syringes.
Technical services are available providing support for all aspects of lyophilization.
Posted Date: 12/3/2020
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