Case Studies
Capsule Tech Transfer Rescue
Case Studies
Capsule Tech Transfer Rescue
Abstract
Challenge
A pharma company was in the process of tech transferring a powder-filled capsule program to a CDMO, but the program ran into difficulties when transfer batches at the CDMO showed poor content uniformity, and their process team could not find a solution. The whole transfer was at risk. That’s when the Bend Bioscience team in Gainesville, Georgia stepped in.
Objectives
Take over the tech transfer, solve the process variability issue, and pass process performance qualification (PPQ) to move production to Bend Bioscience’s Georgia facility.
Case Studies