2 Key Ways in Which Blockchain Can Enable Pharmaceutical Manufacturing and Supply Chain

Building on the advantages of blockchain technology, Tushar Sinkar take a step forward to discuss ways in which blockchain can enable Pharmaceutical Manufacturing and Supply Chain. He presents use cases to establish blockchain’s ability to combat counterfeit drug production and its contribution in Autologous Therapy, which requires a high level of confidentiality, integrity and availability.

In our previous blogs, ‘Disruptive Innovation of Blockchain and Evolution of Pharmaceutical Ecosystem in Data Integrity and Transparency‘ and ‘Blockchain in Drug Discovery and Development,’ we explored how blockchain can assist us in establishing the desired triad of traits – confidentiality, integrity and availability (CIA). Let us now explore more about how blockchain can enable Pharmaceutical Manufacturing and Supply Chain.

Use Case 1: Tackling Sub-standard Products and Counterfeits

Blockchain in pharma manufacturing and supply chain has a compelling case. The chain of custody of a drug in the pharmaceutical sector starts from the manufacturing center where it was first developed and manufactured and is then transferred to distributors before it is distributed to pharmacies and finally delivered to patients.

As data passes through various systems, there is a chance that it may be misinterpreted, altered, or tampered with in an effort to introduce sub-standard or counterfeit medicines, with or without the owner’s knowledge or consent. Such tampering can lead to a lot of chaos in pharmaceutical manufacturing and the supply chain.

Blockchain can put a stop to attempts of introducing sub-standard products and counterfeits. Using the power of smart contracts and distributed ledgers, proof of work and immutability, regulatory, and contractual obligations can be easily addressed. It can create an immutable ePOD (Electronic Proof of Delivery) with an indisputable record of the freight’s history, linked to a digital agreement, essentially a smart contract. Additionally, because data is stored in a decentralized manner, the integration of data is simplified—all systems connect to a single node to access trusted data [1].

Figure 1: Illustration on showcasing chain of custody aiding in the detection of counterfeits and sub-standard drugs in legal chain

Blockchain’s transparency and security-by-design aspects, which keeps data copied across all the nodes, allows the entire supply chain system to become highly resilient to cyber attack.

Use Case 2: Autologous Therapy

The essentials of building efficient and effective manufacturing and logistics strategy for the management of cell-based treatment (Autologous Therapy) include selecting and maintaining the right medium transport unit, managing and monitoring the chain of custody throughout the transit, and maintaining and monitoring the cryogenic temperatures during the transit.

Figure 2 helps us in imagine how blockchain can aid in achieving trust, security, and privacy in the complex scenario of cart therapy (Autologous Therapy).

Figure 2: Blockchain use case illustrating pharmaceutical manufacturing to Supply chain and Distribution workflow

The main advantage highlighted in this use case is blockchain’s ability to manage strict adherence to track and trace requirements, irrefutably prove the actual source of origin, and use of a single track and trace ID, ensuring that the patient receives his own modified harvested cells.

At any point in time, authorized users can monitor the order details status and quality. In fact, during distribution, temperature logs can also be monitored. This way trust, quality, and security can be achieved [2].

To conclude, looking at all of the use cases cited here and in previous blogs, we can say with certainty that blockchain is a disruptive innovation that will lead to evolution of pharmaceutical ecosystem in data integrity and transparency and help the ecosystem in achieving the triad of Confidentiality, Integrity, and Availability or CIA in ‘as-is’ and ‘as-was’ condition.

Bibliography:

[1] “Blockchain for Transportation,” [Online]. Available: https://info.tmwsystems.com/blockchain-technology. [Accessed 20 April 2018].

[2] Dan O’Donnell, “Cell Therapy Logistics – Beyond the Basics,” [Online]. [Accessed 28 April 2018].

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About Tushar Sinkar

mmTushar is a clinical solutions consultant with more than 8 years of experience in implementing cutting-edge solutions in the Life Science and Healthcare domain. His areas of expertise include enabling pharmaceutical companies and independent software vendors in conceptualizing, designing, and implementing clinical trial and real world evidence (RWE) solutions that are driven by semantics and are interoperable, secured, and GxP and HIPAA compliant.


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