Quartic.ai, a manufacturing AI and IIoT platform supplier, and Bright Path Laboratories, a provider of continuous flow reactor technologies, have signed an agreement to develop an AI-powered continuous manufacturing platform for active pharmaceutical ingredients (APIs) and other small molecule drugs.
The agreement will use Bright Path Labs' continuous bioreactor and the Quartic.ai smart manufacturing technology.
The US imports approximately 72% of its APIs used in domestic pharmaceutical production from foreign countries, like China and India. The COVID-19 crisis has quickly exposed significant gaps in the American drug supply.
Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations, said: "In the long term, US pharmaceutical companies should also rethink their supply chains, including by changing the practice of replenishing their inventories just in time and diversifying API supplies to reduce dependence on Chinese and Indian manufacturers."
Bright Path Labs' advanced continuous flow Spinning Tube-in-Tube (STT) 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. Bright Path Labs' advanced manufacturing technology is also directly scalable from development bench, to skid, to modular full-scale commercial operations in months, as opposed to the years that are typical.
"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's CEO, Rajiv Anand.
"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. We also know that this advance technology can provide higher process control and compliance; exactly the capabilities that FDA is urging the industry to accelerate. 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 we are manufacturing using the STT continuous flow reactor," said Tony Quinones, CEO of Bright Path Labs.