| 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:
- Fully one-third of all pharmaceutical PACs are filed by biotech companies.
- PAC-related activity is widespread, with sponsors initiating a significant multiple of PACs relative to marketed products.
- Respondents assessed about 60% of all changes as “major” and 85% of those as reportable to regulators.
- Technology transfer or testing changes were cited as justification for 69% of PACs.
- The highest percentages of PACs (71–89%) arose in response to equipment and plant changes — compared with just 60% from technological innovation.
- Nearly two-thirds (64%) of survey respondents cited raw-material replacement, the “unknown unknown” of ingredient procurement, as a cause for initiating a PAC.
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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