Five-Point Checklist For Pharmaceutical Scale-Up

By David Watt, Technical Director, Business Development, WellSpring and Norm Fong, Technical Transfer Manager, Business Development, WellSpring

Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. A successful drug product may go through a scaling process several times during its life cycle. The laboratory-scale batches used in clinical trials that expand to pilot-scale and finally to commercial-scale production may be just one iteration in a product’s evolution.