Lyophilization Technology

Development Sciences

Carrie Shults"We focus on bringing our client's products from drug discovery and advancing them to our clinical manufacturing by developing an appropriate product specific formulation and a robust lyophilization process. Our goal is to move the product through to making clinical material in a seamless streamlined process. We achieve this with high quality due to the truly exceptional team of dedicated people I work with every day." - Carrie A. Shults, Research Scientist, Group Leader

Development and Process Laboratories

Development services are conducted with a GMP mindset and a focus on product manufacturability and quality. This entails considering product administration, stability and processing requirements from the start. 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.

Following applicable GMP principles, the development and process laboratories are well equipped for conducting a diverse range of experiments encompassing formulation development, cycle design, 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.

When you’re ready to engage, capitalize, and benefit from our expertise, flexibility, and reliability contact us so we can start your product development on the path to success.