Personalized treatments, like autologous cell therapies, are based on a concept that involves a single patient’s input, either in the form of physical raw material (e.g., blood or tissue cells) or of data based on the patient’s analysis to produce a medicine specifically for this patient. This results in a batch size of one for production and thus has very little potential for productivity increases that may be achieved by core manufacturing improvements.
A complex challenge for modern Supply Chains
Personalized treatments pose the related supply chains to several challenges, resulting from the fact that different parties are involved, like pharma companies, hospitals, logistics service providers etc., and at the same time very sensitive data is processed, that allows absolutely no mistakes:
- Data Protection: The data of the whole supply chain process cannot be shared with all parties, but control mechanisms still have to be in place.
- Chain of Identity: The data of the whole supply chain process cannot be shared with all parties, but still a consistent chain of identity is crucial to the success of the treatment.
- Chain of Custody: In many legislations, a consistent chain of custody is a requirement to get commercial approval to sell a new medicine.
- Orchestration and Automation: The whole supply chain is a heavily distributed manufacturing process involving many different external parties
- Conditional Checks and Dependencies: Furthermore, due to the high interdependency of some production steps, additional repetitions or quality checks may be required before the final product can be released.
First reference implementation
DELL Technologies, Hypertrust Patient Data Care and Camelot ITLab have now realized the first Reference Implementation based on Blockchain technology and further components. Do learn more about this case and see the full architecture, you can download the joint whitepaper “Reference Implementation – Hypertrust Patient Data Care X-Chain for Personalized Medicine”. For any further questions, feel free to contact us!