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.
Combining your development and clinical manufacturing at a capable source whose focus is on the unique needs of a lyophilized product can reduce costs, improve efficiency, and mitigate risks along the way, while shortening your timelines to accelerate delivery to your patients in need. When selecting such a partner there are key areas one must consider. A Contract Development Manufacturing Organization, CDMO, with flexibility, extensive capabilities, and a focus on your delivery needs can accelerate moving your product from development through producing Clinical Trial Material much quicker than those with more diverse areas of expertise.