Regis completes expansion of US-based API development facility

The CDMO doubles its capacity to take on new development projects

The expansion, which doubles the small molecule API specialist's capacity to take on new development projects, is now fully operational.

It increases capabilities across Regis’ custom pharmaceutical service offerings, including analytical development, process chemistry, solid state chemistry, validation, stability studies, and commercialization.

The contract development and manufacturing organization (CDMO), which specializes in serving the API development and manufacturing needs of mid-sized and emerging pharmaceutical and biotechnology companies, launched the new lab expansion initiative 2 years ago in response to customer demand.

“The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said Joe Miller, CTO at Regis Technologies.

He added: "The desire to reduce supply chain risk, ensure quality, and maintain intellectual property is driving a surging interest in domestic on-boarding of API development and manufacturing."

The new 9,000-sq.ft expansion includes additional process chemistry and analytical laboratories, a dedicated ICP-MS suite, additional climate-controlled storage, 14 additional fume hoods, several new kilo-scale reactors, and process safety equipment for reaction calorimetry measurements to ensure safe control and scale-up.

In addition, the new laboratories have an advanced variable air volume air system for clean energy-efficient operations.