Blockchain Pilot Targets Supplier Compliance
ChainScore Labs is piloting a blockchain-based system for automated supplier compliance certification in the pharmaceutical supply chain. The technology aims to streamline regulatory checks and reduce counterfeiting risks for raw materials. For CDMOs, this approach could extend digital traceability and trust for ancillary materials used in GMP manufacturing.
- Lot-to-lot variability in raw materials can significantly impact drug product critical quality attributes (CQAs) like purity, stability, and identity, potentially causing out-of-specification (OOS) results and affecting process yields. - Ancillary materials (AMs) used in cell and gene therapy manufacturing, such as media and cryopreservation agents, lack definitive global regulations, creating ambiguity and forcing manufacturers to develop their own risk-based qualification programs. Even materials from reputable vendors can have issues, and since the final cell therapy product often cannot be sterilized, the quality of these inputs is critical. - The Drug Supply Chain Security Act (DSCSA) in the U.S. mandates an electronic, interoperable system to trace prescription drugs, driving the adoption of technologies like blockchain for enhanced traceability and verification. - Beyond compliance, blockchain can be integrated with IoT sensors to monitor and create an immutable record of environmental conditions, such as temperature and humidity, which is critical for maintaining the integrity of sensitive biologics during shipping and storage. - The pharmaceutical industry's reliance on overseas manufacturing for over 80% of Active Pharmaceutical Ingredients (APIs), primarily from China and India, creates significant supply chain vulnerabilities, making robust digital systems for supplier verification a key resilience strategy. - Industry groups like the Pharmaceutical Supply Chain Initiative (PSCI) highlight the expanding scope of supplier compliance, which now includes anti-bribery processes, decarbonization, climate resilience, and, for the first time, biosafety related to the containment of biological substances in manufacturing. - This type of digital ledger technology is a foundational element of "Pharma 4.0," enabling the creation of more accurate digital twins of the manufacturing process and supporting the shift toward real-time release and continuous manufacturing.
