Ambrosus, Trek Therapeutics partner to track quality in pharmaceutical manufacturing via blockchain-powered method
Ambrosus, a Swiss-based blockchain ecosystem for global supply chains, and Trek Therapeutics, PBC (Trek), a US-based private, clinical stage public benefit corporation developing treatments for serious infections with the aim to make them affordable for global populations, announced in a joint press release CoinReport received a partnership under which Ambrosus will apply integrated sensors together with blockchain-based technology to pharmaceutical drug manufacturing in Trek’s clinical development program.
Uniting blockchain and high-tech sensors, and powered by smart contracts, Ambrosus is developing the world’s first publicly-verifiable, community-driven ecosystem to ensure the origins, safety and quality of vital products, such as food, medicine and commodities. Ambrosus will carry out pilot projects with Trek to monitor the integrity, safety and quality of all stages of the pharmaceutical manufacturing process.
“Currently the pharmaceutical manufacturing process is highly regulated by pharmaceutical manufacturers and by regulatory authorities in an extremely labor-intensive and expensive manner,” said Trek co-founder and CEO Dr. Ann Kwong in the press release we received. “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.”
She added, “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.”
Ambrosus co-founder and CEO Angel Versetti stated, “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.”
The pilot projects will involve Ambrosus’ protocol working to track and verify the whole manufacturing chain from the primary chemical starting materials through various stages of synthesis, purification and verification of the active pharmaceutical ingredient (API). This will be followed by formulation of the API into drug product; packaging, labeling, storage and shipping to clinical trial sites.
“Backed by a superb core team of developers, advisors, and researchers, Ambrosus’ protocol will provide the transparency necessary in our manufacturing process to help ensure the integrity of supply chains. With our commitment to providing affordable high quality medicine, we believe this partnership could revolutionize the pharmaceutical industry quality control of manufacturing at every stage from plant to patient,” Dr. Kwong said.
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