Bright Path Laboratories, Inc. (BPL), a provider of continuous flow reactor technology, was accepted into the FDA's Emerging Technology Program, paving the way for the company to provide its low-cost and scalable technology to the domestic API manufacturing sector.
The Emerging Technology Program was created to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing and allows private companies the opportunity to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of new technology.
The U.S. imports approximately 72% of its APIs used in domestic pharmaceutical production from foreign countries, including China. An overreliance on API imports presents national security, supply chain and public health risks.
Some of the factors influencing offshoring of API production can be attributed to traditional drug production processes requiring a large factory site, worker safety and environmental liabilities, and a low-cost labor force. According to Dr. Janet Woodcock of the FDA, "A U.S.-based company could never offset the labor and other cost advantages that China enjoys simply by achieving higher productivity when using traditional pharmaceutical manufacturing techniques."
In contrast to traditional batch manufacturing techniques used in API production, BPL's scalable continuous manufacturing technology is designed to be able to send starting materials through an uninterrupted process until the final API product is complete. Although regulators have been in support of continuous pharmaceutical manufacturing for years, industry has been slow to adopt it due to prohibitive costs and business models built on batch processing techniques, as well as scalability challenges with existing continuous flow technologies.
"As a younger company, we are not burdened with older facilities or equipment. Additionally, 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 BPL’s CEO, Tony Quinones.