Sustained Release Microspheres: Achieving success from post-feasibility to GMP manufacturing
Monday, July 26th - 9am EDT
The drug delivery industry typically focuses on new technologies and confirming proof of concept studies. However, one of the true challenges begins post-feasibility in scaling the desired formulation without impacting critical quality attributes, as well as transferring the process from a R&D laboratory to a GMP manufacturing facility to initiate clinical batch production. This talk will outline the typical steps Oakwood takes during the post-feasibility, scale-up, technology transfer, and Phase 1 clinical batch production. We will discuss some of the challenges we have encountered with previous projects, and solutions to optimize success.