Development Sciences: Development and Process Laboratories
Available from Lyophilization Technology, Inc.
Development services are conducted with a product quality and manufacturing mindset. This entails considering product administration, stability and processing requirements from the start.
Our distinct development and process laboratories are well equipped for conducting a diverse range of experiments encompassing formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale manufacturing environment. Critical areas for fill/finish are all within a certified HEPA environment, emulating aseptic operations for sterile product. Our comprehensive development reports readily support your regulatory submissions.
A qualified facility, with systems and equipment maintained within GMP compliance, is suitable for both development studies and preparing material for stability studies. Capabilities for preparation, processing, as well as finished product testing are now available for biologicals, oncology products, and highly potent compounds.
Services may be provided using our laboratory facilities and when appropriate, on-site visits. Clients and project sponsors realize numerous benefits from the focus on lyophilization, with access to a comprehensive range of services available from a single source.
LTI now offers: Praxair ControLyo™, Nucleation On Demand, and cartridge/syringe capabilities.