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Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
Trek Therapeutics (Cambridge, Mass), which is developing therapies for infectious diseases, is working with Ambrosus Technologies of Switzerland, to test the use of blockchain to ensure supply chain safety and quality.
Ambrosus has been developing what its senior executives call a community-driven supply-chain ecosystem, which uses integrated sensors and smart contracts to record, monitor, and use historical product data (e.g. temperature) as well as transactional data to ensure product safety and quality and supply-chain transparency.
“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,” says Trek cofounder and CEO Ann Kwong. “Our goal is to develop a system that is robust enough so that we can submit data to support our manufacturing application for regulatory approval of our drugs from the FDA and EMA authorities,” she added.
Another important goal, Kwong says, is to provide an environment that allows all stakeholders, and particularly patients, to ascertain the quality of medicines they take. Currently, she says, patients have no way to ascertain this quality.
Ambrosus’ blockchain protocol has already been tested and implemented in food supply chain applications.
“The pharmaceutical supply chain encompasses many phases, and a multitude of stakeholders, requiring responsible parties to seek new methods of guaranteeing the quality and integrity of critical products,” said Ambrosus CEO Angel Versetti. “Our partnership will help to develop protocols to provide transparency and quality assurance during each phase of the process.”
As part of the pilot, Ambrosus’s protocol will be tested to verify and track the entire manufacturing chain, from primary starting materials through synthesis, purification, and verification of API; followed by formulation of the API into drug product; packaging, labeling, storage, and shipping to clinical trial sites.
Kwong believes that Ambrosus’ protocol will provide the transparency required to ensure supply chain integrity. If tests succeed, she says, this approach could transform pharmaceutical quality control for manufacturing, at every stage from plant to patient.
The project could stretch the boundaries of what blockchain technology can accomplish in real-world applications, notes Jason Lukasiewicz, founder and former CEO of the bitcoin-based financial technology company, Coinsetter, and former CEO of the Canadian bitcoin exchange, who recently joined Ambrosus as an advisor.
Source: Company Blog