Regis Technologies recently opened a new potent compound suite (PCS) for custom manufacturing of highly potent active pharmaceutical ingredients (HPAPIs). The company invested in this project to extend their custom cGMP offerings to the oncology market.

Regis operates a 36,000 square foot, cGMP facility in Morton Grove, IL. The PCS addition provides for small molecule cGMP manufacturing of potent compounds up to about one kilogram per batch. PCS targets small molecule oncologicals and linker payload projects for antibody drug conjugates.

The CMO says it spent two years designing and constructing the suite and preparing its team for the new potent compound capabilities. So far, 11 employees have completed the required hands-on training. To ensure retention and safe practices, Regis will require the PCS team to pass a safety review prior to each campaign. The PCS is now qualified and ready to host projects.