Right antihama, modern pharmaceutical supply chains are highly decentralized, with APIs manufactured in one region of the world, formulated in another, and packaged in a third. There are considerable risks inherent in this process, and current verification methods don’t provide the level of control needed throughout the supply chain, so product integrity can be compromised. In 2013 the FDA established the Drug Supply Chain Security Act (DSCSA) to identify suspect or illegitimate products in the supply chain. It mandates that companies serialize products and implement a track and trace system to track their product throughout the entire supply chain, among other requirements. There are several stages, with full implementation required by 2023, which is why blockchain has become attractive.
And yes, the supply chain is far more critical for personalized advanced therapy products, which require cryopreservation. Every shipment is monitored in real time, and each shipping container has data loggers that report not only location, but all conditions like internal temperature, external temperature, orientation, light, humidity, and pressure, which are part of the chain of condition. The name of the courier and all personnel who handle the shipment at each point of contact are recorded, and are part of the chain of custody. Other documentation includes all patient data, the date, time, and GMP facility where the batch was manufactured, product labeling, the registered medical doctor and treatment center information, etc., so yes, I think the chain of compliance basically certifies that the advanced therapy product is authentic, meets regulatory and quality requirements, and complies with good distribution practices. Due to the complexity, personalization, and novel nature of some advanced therapies, it isn’t even possible to directly compare batches of the final product in the same ways that are used for conventional biologics. I haven’t really dug into the import/export regulations to know if there are additional requirements though.
