Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.
Our distinct development and process laboratories are well equipped for conducting a diverse range of experiments encompassing product design, formulation development, thermal analysis, cycle design, and process refinement, as well as evaluating finished product.
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Our EU and US compliant Clinical Manufacturing Operations are capable of processing sterile Pre-clinical to Phase II Clinical Materials, lyophilized and liquid products in vials, cartridges, bulk, or your unique delivery system. Containment capabilities include handling biologicals, cytotoxic, and high potent APIs.
LTI Technical Services support product and process troubleshooting, CMC section of a regulatory submission and batch record review, consulting on equipment specifications, process requirements, process validation, process excursions, technology transfer, and compliance auditing.