The manufacture of vaccines and therapeutic proteins has suffered from a reputation of being part art and part science, with heavy doses of regulatory uncertainty thrown in. Postapproval changes (PACs) to chemistry, manufacturing, and controls (CMC) were initiated reluctantly and carefully in the era of “the process is the product.” Today, CMC PACs are a normal part of the biopharmaceutical industry business.

Emma Ramnarine (head of global biologics quality control at Hoffmann-La Roche in South San Francisco, CA) notes that “reasons for PAC improvements can be varied: staying current with industry trends and regulatory expectations, driving optimization of processes or methods, innovation in technology, addressing aging facilities and equipment, improvements in efficiency, and addressing manufacturing/ quality issues that can impact cost of goods (CoG).” Speaking at a PDA event in April, 2017, Ramnarine reported some interesting statistics:

Those are the core drivers behind big-picture rationalization for PACs such as “continuous improvement,” “patient access,” “quality,” and others. Although it would seem to be the most obvious reason for initiating changes, CoG turns out to be relatively insignificant.

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