Lyophilization Technology, Inc. services

Start off on the best path towards your product approval. The route of administration and other unique requirements of the product which make up the Target Product Profile (TPP) are considered during whole product design. This approach ensures the final product is practical and efficient, in addition to effective, in order to limit changes during the lifespan of the product. Taking advantage of great relationships with vendors of varied container closure systems and other industry experts, Lyophilization Technology, Inc. can assist in conceiving, selecting and/or evaluating a wide range of potential product designs to meet your needs

Benefit from the wealth of knowledge and experience of our scientific team in developing your product formulation. Based on the physico-chemical requirements of the active compound, multiple variations of a formulation are investigated to yield a preparation having superior finished product attributes and adequate long-term stability.

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.

Lyophilization Technology, Inc. is an expert in establishing processing procedures for clients that are safe, effective, and sufficiently robust for integrating into commercial manufacturing. Process refinement, troubleshooting, and technical transfer are additional services we provide. Whether your product had been designed by trial and error or lacks development data, and regardless of where you are in the product life cycle, LTI will work with you to improve your process.

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.

Scale-up of an early stage manufacturing process provides unique challenges. Lyophilization Technology, Inc. conducts all development studies with a manufacturing mindset from the start and is uniquely adept at facilitating the technical transfer process. From Development through Clinical Trial Material preparation, lyophilization occurs in qualified pilot and small manufacturing size units with comprehensive automation and process monitoring. This allows for aid in scale-up and technical transfer.

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.