Cell and gene therapy: supply chain blockages need industry-wide solutions
Since there is still relatively limited precedence to cell and gene therapy (CGT) manufacturing, there are many opportunities for improvement, specifically in raw material and product supply chains.
Actionable Insights:
- Interoperability among stakeholders and standardization of processes are essential for robust CGT supply chains: The cloud can assist with transparency – such as product location in real time – but there are still many opportunities for improvement, such as efficient integration of patient data
- Economies of scale can help ensure raw materials are on site when they are needed: Efficiencies on packaging and label design processes should be investigated
- Precision analytics and artificial intelligence (AI): Helps find potential future bottlenecks that can be addressed now
Since CGTs are specifically made for each patient, manufacturers need to find ways to optimize operations. There are key challenges faced by CGT manufacturers: product variability, complex manufacturing procedures, high infrastructure costs and maintaining supply chains. These challenges are the same for all manufacturers and thus collaboration among stakeholders is necessary to find solutions.
CGT supply chains cover the process of transferring samples from healthcare providers to the manufacturing hub and transporting the product to the treatment site. There is also a separate supply chain of raw materials sent to the manufacturing hub. Microsoft’s David Rhew noted: "We could try to figure it all out on our own, but it just becomes too expensive for any one organization to handle this [supply chain] themselves.”
Interoperability of technology is essential for robust and reproducible CGT supply chain. “There has to be smooth handoffs [among key locations] and, to have smooth handoffs, you need interoperability and agreement on standards," Rhew added. There should be interoperability among these stakeholders: regulatory bodies, manufacturing hubs, raw materials providers, treatment sites, sample collection sites, and delivery companies.
Cloud computing allows stakeholders end-to-end visibility of where products are in the supply chain and a way to store patient data. Since CGT operations are still a work in progress, there are existing questions on how to best use the cloud. As Rhew added: “How do we make sure that the cloud, in its ability for us to move data, is done properly? How do we incorporate patient data into the supply chain?”
There are also opportunities on how to ensure raw materials are available at the manufacturing hubs when they are needed. A potential way to address this is via economies of scale, in that the more products a site can manufacture, a higher volume of raw materials can be stored on site without negatively impacting budgets.
There are also efficiencies to be found in improving CGT packaging and labeling. It can take months in designing the right package, as there are guidelines that need to be met on what should be on the label to ensure the product reaches its correct destination. Standardization of packaging and labeling can shorten manufacturing timelines.
To prevent bottlenecks, forecasting tools such as predictive analysis and AI can help identify future issues. These technologies use real-world data, and thus it is also essential to find ways to collect the data efficiently.
Industry Experts Who Contributed:
All contributors are senior leaders within the cell and gene therapy industry
- Ariette van Strien, President, Marken
- Orlando Serani, Program Lead, Advanced Cellular Therapies Supply Chain, Johnson & Johnson
- Dr David Rhew, VP of Healthcare, Global CMO, Worldwide Commercial Business, Microsoft
- Joerg Ahlgrimm, (formerly) COO, Center for Breakthrough Medicines
- Moderator: Adlai Goldberg, Global Digital, Social, and Commercial Innovation Life Sciences Leader, EY