Quartic.ai and Bright Path Labs announced today that they’ve agreed to develop an AI-powered continuous manufacturing platform for active pharmaceutical ingredients (APIs) and other small molecule drugs.
The technology will use Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.
The companies are touting the technology as a way to diversify supplies of APIs, many of which are presently in countries including China and India. The COVID-19 pandemic has raises concerns about U.S. reliance on drug ingredients made elsewhere.
“We are excited about the collaboration with Quartic.ai to demonstrate that digitally-enabled smart manufacturing of APIs will be more competitive than offshore imports,” said Bright Path Labs CEO Tony Quinones.
Bright Path Labs’ advanced continuous flow Spinning Tube-in-Tube technology can rapidly produce chemicals and pharmaceutical active ingredients with higher yields, faster reaction times, greater purity — and does so using reaction and process chemistry founded on the principles of green chemistry and green engineering, according to the company. Bright Path Labs also claims that its advanced manufacturing technology is also directly scalable from development bench to skid to modular full-scale commercial operations in months, as opposed to years.
“The AI technology provided by Quartic.ai will help speed up the design, validation and approval of molecules to use this technology in line with the Quality-by-Design (QBd) guidelines set by the FDA to assure drug safety. We will be able to make DoE (Design of Experiments) dynamic for process development and technology transfer while also providing continuous monitoring of quality for real-time-release,” said Quartic.ai CEO Rajiv Anand.
Bright Path is working with the FDA’s Emerging Technology Team to integrate real-time AI into the process control strategies for the intermediates actives the company is manufacturing using the STT continuous flow reactor, according to Quinones.
This combined Bright Path Labs-Quartic solution will help strengthen America’s drug manufacturing independence and ensure critical supply of medicines to patients.