DSM certified for potent compounds

DSM Pharmaceuticals has earned the SafeBridge Potent Compound Safety Certification for the handling of potent active pharmaceutical ingredients and drug products. The certification applies to a sterile fill/finish production area within the company's Greenville, NC, facility that includes a high-containment area and associated quality control labs.

SafeBridge conducted its 60-element review of programs, procedures, containment and control of APIs at the site. Quantitative results determine that DSM qualifies for the certification.

SafeBridge in July certified SAFC, a member of the Sigma-Aldrich group, for the high-potency suite for antibody drug conjugate manufacturing and process development and associated quality-control labs at a St. Louis facility. Both SAFC and DSM hold the SafeBridge certification for high-potency areas at other facilities as well. They are joined by Lonza and Ferro-Pfanstiehl as certificate holders.

- here's the announcement

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.