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Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.
Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology, the companies announced in a May 6, 2020 press release. The companies suggest that this type of continuous manufacturing platform would allow API manufacturing in the United States to be competitive with imported APIs.
“We believe in technologies like AI as key enablers for manufacturing excellence. 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 Tony Quinones, CEO of Bright Path Labs, in the press release. “We also know that this advanced technology can provide higher process control and compliance, exactly the capabilities that FDA is urging the industry to accelerate. Bright Path is working with FDA’s Emerging Technology Team to integrate real-time AI into the process control strategies for the intermediates actives we are manufacturing using the Spinning Tube-in-Tube (STT) continuous flow reactor.”
Bright Path Labs says that its STT technology can produce chemicals and APIs with high yields, fast reaction times, and high purity, using green chemistry and green engineering principles. The technology can be directly scaled from development bench, to skid, to modular full-scale commercial operations in months, the company said in the May 6, 2020 press release.
“Scalability is not an issue for our technology, since the parameters that control the (chemical) reactions don't change as the size of the reactors are increased. This means we are better positioned (than traditional batch technology) to help put cutting edge (small molecule) therapies into the hands of patients more rapidly and cost effectively,” said Quinones in a March 18, 2020 press release discussing its acceptance into the FDA’s Emerging Technology Program.
“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 guidelines set by FDA to assure drug safety. We will be able to make design of experiments dynamic for process development and technology transfer while also providing continuous monitoring of quality for real-time-release,” said Quartic.ai’s CEO, Rajiv Anand, in the press release.
Source: Bright Path Laboratories