How Scale-Up Benefits A Clinical Program To Get Results

By M. Omon Herigstad, Principal Scientist/Group Leader, Scale-Up Lab, Evan Pasenello, Account Manager, Operations Contract Manufacturing, Mark A. Shannon, Scientist II, Paul M. Reynolds, Senior Scientist II, Andrew S. Bulger, Scientist II, AbbVie

Progression of promising drug candidates from early pre-clinical evaluation through to clinical trials and eventual commercialization requires a scalable manufacturing process. Not only does scalable manufacture promise increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, but it also helps with timely delivery to market, translating to a competitive advantage when it comes to gaining market share.

Transitioning the production of microbial and cell culture-derived biologics to a scale suitable for clinical or commercial supply can be challenging. In contrast to small molecules, biologics often demonstrate complex, scale-dependent behaviors. This makes switching from small-scale manufacturing to full-scale production more difficult, highlighting the importance of well-defined scale-up principles to support a predictable transition.

With a proven track record in manufacturing biologics at the varying scales required to support IND-enabling non-human pre-clinical studies, AbbVie’s scale-up laboratory (SUL) demonstrates process scalability in the non-GMP space to afford considerable financial benefit. Using equipment, materials and methods representative of commercial-scale production, highly skilled personnel rapidly optimize key process control parameters to assure delivery of reproducible product. This builds confidence in the process and its scalability prior to GMP manufacturing and can expedite the biologics development lifecycle by circumventing costly program delays.