Regis, which specializes in supplying the API development and manufacturing needs of mid-sized and emerging US pharmaceutical and biotechnology companies, said the expansion increases capabilities across its custom pharmaceutical service offerings, including analytical development, process chemistry, solid state chemistry, validation, stability studies and commercialization.

Specific upgrades include 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, Regis said, the new labs have an advanced variable air volume (VAV) air system for clean energy-efficient operations.

“The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said chief technology officer Joe Miller. He added that the focus on top quality end-to-end API development and manufacturing services for clinical-stage companies as well as commercial-stage firms serving medium-sized, rare disease and other specialty markets enables the company to provide a comprehensive range of services tailored to customers’ individual needs.

Customer 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 CTO said.

Author: Dede Williams, Freelance Journalist