Scale-Up Getting It Right the First Time

Abstract

Scale-up is becoming a more finely tuned process, with scaleout and scale-down playing more important roles. "Speed to clinical phases is faster now, and biopharmaceutical manufacturers are targeting smaller patient populations and specialized drugs in order to access the market faster, reach patients, and get financial returns sooner than ever before," says Stéphane Varray, head of commercial development in Lonza Pharma and Biotech's mammalian and microbial development and manufacturing business unit. [...]he says, it has scaled all biopharmaceutical processes up directly (i.e., in one pass) since 2012, where previously, efforts may have required going back to the drawing board. Solid dosage scale-up Within the past five years, pharmaceutical manufacturers have become more comfortable with advanced process control and are embracing other advanced manufacturing concepts, says Fernando Muzzio, professor of pharmaceutical science at Rutgers and head of the Center for Structured Organic Particulate System (C-SOPS), which has been focusing on tech transfer and commercialization of continuous manufacturing processes for solid dosage forms.