Lyophilization Technology, Inc. services
Development Sciences
Lyophilization - Formulation Development Service
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.
Lyophilization - Pilot Plant Scale-up Service
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.
Lyophilization - Product Design Service
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
Lyophilization - Cycle Design / Refinement Services
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.