By Jenny Dunker, Global Product Marketing Manager, Bioprocess Hardware at Cytiva
Transfer from a non-GMP to a GMP environment is a resource-intensive step in biomanufacturing. As you are moving from late stages of process development to pilot production your process need to work as well in a regulated environment. There are, however, ways to make the transition less resource demanding.
Dr Alison Ward at ASLAN Pharmaceuticals in Singapore and Avril Vermunt, Bioprocess Hardware Specialist at Cytiva shared some tech transfer insights with me. The common theme was to start with the end in mind. It pays off to determine the target product profile (TPP) for your drug candidate as early as possible.
This approach will help guide you through the development. And it will let you focus on important product quality attributes. Interested in specific tips on how to use this approach to prepare for GMP work? Keep reading.