Regulation & Policy
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Ambrosus, the world’s first trusted blockchain-based ecosystem for the supply chain, announced a partnership with pharmaceutical pioneer Trek Therapeutics, PBC (Trek) to apply integrated sensors coupled with blockchain-based technology to pharmaceutical drug manufacturing in Trek’s clinical development program. This announcement comes as blockchain industry heavyweight Jaron Lukasiewicz joins Ambrosus as Strategic Advisor.
Combining high-tech sensors, blockchain, and powered by smart contracts, Ambrosus is building the world’s first publicly-verifiable, community-driven ecosystem to ensure the quality, safety, and origins of essential products, such as medicine, food and commodities. As part of the collaboration, Ambrosus will conduct pilot projects with Trek to monitor the quality, safety and integrity of all stages of the pharmaceutical manufacturing process.
Trek Co-founder and CEO Dr. Ann Kwong said, “Currently the pharmaceutical manufacturing process is highly regulated by pharmaceutical manufacturers and by regulatory authorities in an extremely labor-intensive and expensive manner. We hope to partner with Ambrosus to create a continuous monitoring and tracking system that will be less labor intensive, less expensive, and more transparent to all parties with a stake in quality pharmaceutical manufacturing. Our goal is to develop a system that is robust enough that Trek can submit data to support our manufacturing application for regulatory approval of our drugs from the FDA and EMA authorities.”
“Additionally, patients currently have no way to ascertain the quality of the medicines they ingest. Trek believes it is important to be able to demonstrate to patients that while our drugs are affordable, they’re also of the highest quality,” Dr Kwong added.
Ambrosus Co-Founder and CEO Angel Versetti said, “Following the successful implementation of the Ambrosus protocol in global food supply chains, we are delighted to now apply our blockchain protocol to help ensure the quality, safety and integrity of another vitally important product – pharmaceuticals.”
As part of the pilot projects, Ambrosus’s protocol will work to verify and track the entire manufacturing chain from the primary chemical starting materials through multiple steps of synthesis, purification, and verification of the active pharmaceutical ingredient (API); followed by formulation of the API into drug product; packaging, labeling, storage, and shipping to clinical trial sites.
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