Facility Design Considerations

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John Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.


The Pharmaceutical Technology Group spoke with John Bertagnolli, vice-president of Commercial Operations, at the 2024 CPHI North America event, about what it takes to create a new pharmaceutical facility. According to Bertagnolli, the building of greenfield facilities by contract manufacturing organizations (CMOs) is a new trend in the outsourcing industry. “It's usually an aging … pharma-owned, Big Pharma-owned facility [that is] repurposed as a contract manufacturing organization, or an existing company has … other parts of it built on so that they can do different parts of contract manufacturing,” Bertagnolli says.

He points to three milestones that CMOs should meet when building a new facility: completion of the facility, completion of the first aseptic process simulation (APS), and regulatory approval and manufacture of the first product. “[W]hen we're talking about the APS, it's what used to be referred to as the media fill, but [FDA] has put some much … tighter bounds around what they call aseptic process simulation. And because of that, it truly is the final exam for a facility to say, yes, we know we can manufacture sterile product to the correct level that would meet [FDA] requirements. [I]n the case of building a brand-new greenfield site, that also means that you've done all of the characterization of the site from a microbiological perspective, so that you know how all the monitoring is done, that all of the utilities have been established and validated, and you have data to make sure that they're doing exactly what they should be doing.”

Click the video above to watch the full interview. CPHI North America occurred May 7–9 in Philadelphia.