Facility certified for potent APIs

SAFC, a member of the Sigma-Aldrich group, has been certified and deemed proficient in the safe handling of potent active pharmaceutical ingredients (APIs). The certification, granted by occupational health and safety concern SafeBridge Consultants, applies to the high-potency suite for antibody drug conjugate manufacturing and process development, and the associated quality-control labs, at SAFC's St. Louis facility.

SafeBridge conducts assessments of potent compound suites using a 60-element occupational safety review of the programs, procedures, containment measures and controls in place for potent API handling. The consultancy established the certification program several years ago.

Eight companies are or have been certified, according to John Farris, SafeBridge president and CEO. Among those currently holding certifications are contract manufacturers Lonza, DSM Pharmaceuticals and Ferro-Pfanstiehl, as well as a suite at another SAFC location. "It's now beginning to snowball," says Farris of demand for the certification, which he says can be used as a continuous improvement tool and a tool for gap assessments. He adds that contract manufacturers use the certification both to protect workers' health and to gain a leg up on competitors.

Farris says he sees the growing number of big pharma and contract manufacturers working with high-potency compounds as a result of drug developers focusing on more targeted molecules than in the past.

Recent announcements of manufacturing services for high-potency compounds have come from Norwich Pharmaceuticals, Azopharma and Helsinn, though none mentioned the SafeBridge certification.

- here's the Safebridge announcement
- see the Norwich release
- here's the Azopharma release
- here's our Helsinn coverage

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.