Regis Technologies, a contract development and manufacturing organization (CDMO), has completed a major expansion of their laboratory facilities for the development of active pharmaceutical ingredients (APIs) located in Morton Grove, IL. The expansion, which doubles the company’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.
 
Regis specializes in serving the API development and manufacturing needs of mid-sized and emerging pharmaceutical and biotechnology companies. Their combination of high quality, full-service CDMO offerings and individualized customer attention has fueled growing demand for their services. The new lab expansion initiative was launched two years ago in response to this demand, enabling Regis to put the new capacity to work at this time of unprecedented need for U.S.-based comprehensive, experienced API development and manufacturing services.
 
“The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said Joe Miller, chief technology officer, Regis Technologies. “We provide top quality end-to-end API development and manufacturing services for clinical-stage companies and for commercial-stage firms serving medium-sized, rare disease and other specialty markets. This focus enables us to provide a comprehensive range of services that are tailored to our customers’ individual needs.”
 
Dr. Miller continued, “Our investment in this new capacity broadens Regis’ capabilities and our flexibility to support the growing need for U.S.-based custom pharma services. 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. This timely expansion allows us to meet this demand, enabling our scientists to support additional API projects as our customers advance their novel drugs to market.”  
 
The new 9,000-square-foot 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 (VAV) air system for clean energy-efficient operations.