Lyophilization Technology, Inc. services

At Lyophilization Technology, Inc. we understand the unique thermal characterization of your product is key to successful product and process development. Paramount to starting this process is Low Temperature Thermal Analysis (LT-TA). LT-TA evaluates the bulk solution behavior during freezing and drying using varied thermoanalytic techniques at low temperatures. The goal is to quantify critical thermal transitions in preparation for freeze drying. The methods utilized include simple electrical resistance measurements (ER), freeze drying microscopy (FDM), and low temperature differential scanning calorimetry (LT-DSC). This activity provides significant data and warrants focus as a distinct step in the development process. Our stand-alone reports are suitable for submission to the agency.

Product characterization is vital to the development of a robust lyophilized product and process for all formulation and process development. Lyophilized finished product should be evaluated for critical quality attributes (CQAs) specific to a lyophilized preparation. This can include physical appearance, quality of the constituted solution, residual moisture content and thermal properties.

Capabilities for preparation, processing, as well as finished product testing are available for biologicals, oncology products, and highly potent compounds. Preparation of clinical materials in this expanded facility complement the extensive activities currently performed in the conventional development laboratory and pilot plant. Batch preparation, aseptic processing and lyophilization are completed in a unique environment that provides safety and security for product and personnel. This is achieved by a high level of control throughout the operation, supported by the facility layout, processing equipment used in batch preparation, as well as environmental controls.

Lyophilization Technology, Inc. is uniquely equipped to handle highly potent toxic and biohazardous materials. From product characterization and cycle design to scale-up and clinical trial material preparation, we can safely and effectively meet your containment needs.

Complementing LTI`s Development Sciences and Clinical Manufacturing, LTI offers Consulting Services.