A few weeks ago I highlighted one of the three new BioPhorum publications, MES of the Future Manifesto. Today, I’ll highlight a second one, CGT [cell & gene therapy] Actors and Process Maps. Emerson’s Sean Buckley was one of the authors along with co-authors from Roche, Takeda, and BioPhorum. Contributions were made during this Cell and Gene Therapy workstream from numerous biopharmaceutical manufacturers and software & equipment suppliers.
In this document, the relevant organizational units (actors) for CGT supply are defined and shown in diagrams, prompting readers to identify where those actors sit in their own partner ecosystem. The function of each actor in the supply process is shown in a few simple process blocks.
Six common types of CGT are analysed in turn, showing how the pattern of actors and process blocks varies by therapy type. Particular attention is paid to the customer-critical path: the sequence of steps that need to happen within the tight turnaround times of advanced personalized therapies.
The toolkit includes a spreadsheet and presentation which can be adapted to the unique needs of each partner ecosystem. The models can be extended to cover new modalities as they emerge, while still leveraging the commonalities.
Here are the benefits of using this model.
↓ Cost for CGT Manufacturers
↓ Cost for CGT software vendors
↑ Regulatory compliance
↓ Overall time for CGT treatments
↑ Integration between systems
This outline shows the key areas of focus in the document.
- Executive Summary
- IT for cell and gene therapies
- This document and toolkit
- Process blocks
- Coordinating supply chain execution is like conducting an orchestra
- The Digital Plant Maturity Model applied to CGTs
- Actors in the supply of CGTs
- Process blocks for the supply of CGTs
- How the process blocks for CGT supply vary by therapy type
- Made-to-stock genetic vector
- Made-to-stock, assemble-to-order genetic vector
- Personalized cancer vaccines and gene therapies
- Allogeneic cell therapy
- Finish-to-order allogeneic cell therapy
- How to use and adapt these tools
- Analyze the process blocks for your particular therapy modality
- Customize to your own partner ecosystem
Actors and process blocks are defined in this way.
In this document, an ‘actor’ is an organization unit. For example, a treatment center is an actor organization. These definitions help define who needs to use a digital capability to support a CGT product as part of the extended enterprise (i.e. internal and external).
In this document, ‘process blocks’ are shapes on a diagram that illustrate in a simplified way what that actor does as a contribution to the overall process of supplying a CGT. Process blocks are labelled with verbs that are intended as a very high-level summary. For example, ‘Make and test’ could summarize many hundreds of detailed process steps.
If you’d like to learn more, visit BioPhorum’s CGT actors and process maps: Who does what in the supply of different cell and gene therapies page to register (for free) and download the document. Also visit the Life Sciences & Medical section on Emerson.com for more on the technologies and solutions to drive pharmaceutical and biopharmaceutical manufacturing performance improvements.