Making a great product once is a magic trick. The product becomes real only when you can make it reliably, over and over again.

For the longest time, manufacturing in biopharma was treated like the person in the group project who actually did the work but never made it to the title slide. Discovery got the glamour, Clinical data got the applause, and Regulatory strategy held tense conversations on meeting latest FDA requirements. Manufacturing sat quietly in the back, asking inconvenient questions about scale-up, sterility, comparability, and the importance of consistent, reliable therapy.

That will be changing.

On June 29, 2026, the FDA selected 7 companies from more than 80 applicants for its PreCheck Pilot Program. The idea is simple: give new US drug manufacturing stations earlier FDA feedback to help them prepare more effectively for review. (link)

Then, on July 10, 2026, FDA proposed a rule to clarify how distributed manufacturing sites and certain foreign suppliers should register with the agency. (link)

These announcements matter. Even though they don’t seem consequential at first glance.

Modern therapies (biologics, cell & therapies, sterile injectables, and other advanced modalities) come with specific, technical manufacturing needs. These are expensive and require risk assessments and contingency plans.

A strong clinical profile is essential. It is myopic to celebrate after receiving approval with no consideration for manufacturing scalability, supply chain reliability, and robustness of quality systems.

So, companies that treat manufacturing as part of strategy have a distinct competitive advantage.

References
1) https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing
2) https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration