Poor solubility is a major challenge for drug sponsors as the development process is often stalled due to a candidate's low aqueous solubility. A uniquely modified cyclodextrin is emerging as a versatile tool in the formulation process as it significantly improves solubility, stability, bioavailability, and dosing of APIs.
Circumventing human intervention in fill line technology can reduce or eliminate sterility failures and increase efficiency with material handling. Examine how leveraging a fully robotic aseptic filling system enables versatility, high yields, and low losses, as well as precise and repeatable fill parameters batch to batch.
The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines. A detailed conversation at project outset between the scientists and the CDMO avoids many such issues, or at least prepares both parties for potential problems.
Securing a development and aseptic fill/finish partner to support clinical applications can feel like a gamble. A partner with the right manufacturing equipment, communications, and SOPs — as well as flexibility in both internal operations and its client relationships — can optimize your speed to clinic.
