Vein-to-Vein Tracking and Supply Chain Digitisation
This is the second of a series of five blogs summarising key discussion points and outcomes from the latest automation Special Interest Group (SIG) sessions, held in June 2021.
This blog highlights the contributions of the second working group, focussed on ‘Vein-to-Vein Tracking and Supply Chain Digitisation’.
Participants in the June meeting included representatives from cell and gene therapy companies and technology providers. Subject matter experts included those in apheresis cell collection, data management and supply chain associated with these advanced modalities.
The objectives of the group include:
- Creating a single environment/matrix for supply chain data
- Connecting data coming from existing solutions
- Standardizing collection centre data, supply chain data, and manufacturing data
- Identifying data gaps in the manufacturing process and supply chain
For the kick-off session, the team focused on establishing a vein-to-vein view of data requirements for each step in the cell therapy production process from donor collection, to manufacturing and administration of the final product. A baseline of common language and understanding of the process was deemed to be an essential first step.
Session lead, Kathie Schneider, Founder of Accellia, shared her perspective on the need to create this baseline by citing the nearly 30 CAR-T therapy clinical trials from at least 12 different companies underway at Mass General Hospital in Boston:
“….how many different protocols do they have to follow from each of those 12 companies regarding how they handle it, what temperature do they thaw it at, what temperature do they freeze it at, how long before the infusion, what are the components of that? There are multiple pieces to this puzzle that we need to solve and try to make it somewhat consistent.”
Data required to initiate each step in the process, as well as that needing to be transferred to subsequent steps, were outlined. Several gaps were identified across this process and will be explored in subsequent sessions, including the need for consistency related to:
- Maintaining the chain of identify and chain of custody for patient samples and controlling this throughout the process
- Use of apheresis machines and programs as this impacts quality of the collection and what moves to manufacturing
- Labelling as it can be very different depending on where the product is being manufactured
- Shipping temperature – whether ambient or frozen
- Whether cells used for therapeutic purposes are labelled as genetically modified organisms or “GMO”
- The type of data that can be captured about a patient and what ultimately might be on the label
The group’s next meeting will be held in September and the focus will the following topics:
- Review the gaps identified in the June meeting and the determined causes
- Determine which of the identified gaps have actionable solutions
- Discuss which of these gaps are standardisable
- Make recommendations to fill the actionable gaps
Ultimately, the group will publish a White Paper outlining gaps in existing processes, technologies and standards as the industry advances towards vein-to-vein tracking. The group will also provide recommendations to the cell therapy industry on areas of collaboration that will help advance vein-to-vein tracking and supply chain digitisation.
The Automation Special Interest Group (SIG) was created by Phacilitate in 2017 to discuss and propose solutions to automation challenges presented by cell and gene therapy manufacturing. Since that time, we have advanced this mission by identifying key objectives, hosting meetings with industry experts to explore and address these objectives and releasing a report for the wider industry to use as guidance in their automation efforts. In 2021, we evolved the SIG into a parallel track of year-long working groups, each focused on a different area.
Catch up with what was discussed at the June 2021 meetings with this blog series:
1 – Manufacturing Digitisation in Advanced Therapies
3 – Automating Release for Autologous Products
4 – Modularity and Flexibility in Closed Systems
5 – Aligning the Automation and Technology Roadmap to the Regulatory and Process Development Roadmap