News | March 18, 2020

Bright Path Laboratories Accepted Into The FDA's Emerging Technology Program, Paving The Way For Rapid, Low-Cost Domestic API (Active Pharmaceutical Ingredients) Production

Cornelius, NC /PRNewswire/ - Bright Path Laboratories, Inc (the "Company" or "BPL"), a leader in continuous flow reactor technology, was recently accepted into the FDA's Emerging Technology Program paving the way for the Company to bring its unique 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 novel technology.

"We are thrilled that our technology was so well received by the Emerging Technology Team," said Charles W. Gray, Jr., Ph.D., Head of Regulatory Affairs, "as well as their willingness to support our efforts to bring this innovative and exciting technology online as quickly as possible."

As has been reported extensively in the press lately, millions of Americans, including military members, rely on drug products to stay healthy, yet the United States imports over 80% of its APIs used in domestic pharmaceutical production from foreign nations – predominantly China. An overreliance on API imports raises national security, supply chain and public health risks. Retired Brigadier General John Adams told NBC News recently, "Basically we've outsourced our entire industry to China. That is a strategic vulnerability."

The most commonly cited factors for the significant increase in offshoring of API production primarily have to do with the fact that traditional drug production processes require a large factory site, have worker safety and environmental liabilities, and can utilize a low-cost labor force. In fact, 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 large sunk costs, and entrenched business models built upon 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 CEO, Tony Quinones.

As mentioned by Senator Marco Rubio on March 12th on Fox News, "China has tremendous leverage over the United States with respect to our medical supply chain. We need to invest and make available investments into rebuilding this capacity, which is good for American jobs, national security, and economic security."

"We agree with Senator Rubio and are actively looking for additional financial partners to help expand our production capacity as well as pharmaceutical companies who might have an interest in licensing our technology," said Quinones. "We have also been developing a robust pipeline of clients who are seeking a domestic development and manufacturing partner for either key starting materials and/or their API needs."

About Bright Path Laboratories, Inc
BPL was created for the purpose of becoming a market leader in the manufacture of APIs and related pharmaceutical precursors. The company's mission is to bring its disruptive advanced manufacturing technology to industries where its unique chemical production techniques can have a significant impact in helping to solve real world problems (e.g., affordability of medicine, access to rare/orphan disease treatments, precision guided medicine/nutrition, etc.)

Over the last decade, Bright Path leadership has gained significant scientific and technical expertise in the areas of chemical reaction design and intensification, green chemistry, green engineering and process evaluation. This includes the successful development of dozens of chemistry/API methods with BPL's Spinning-Tube-in-Tube ("STT®") technology spanning commodity and specialty organic chemicals, flavors and fragrances, pharmaceuticals, electronic applications, and nanotechnology.

Source: Bright Path Laboratories

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