The workshop hosted by FORTH principal investigator Ioannis Papantoniou explored a 4.0 and self-adapted/managed vision for cell therapy manufacturing. In his presentation, Antleron CEO Jan Schrooten talked about novel tools that support this vision and explained how these tools can fast-track the transition of cell therapy manufacturing from craft to industry in order to sustainably provide next generation cell therapies to patients.
Currently, a lot of cell therapy manufacturers still work with open, manual processes, which are difficult to sustainably scale (up & out) in a cost-effective way. To avoid commercial failure of therapeutically effective ATMPs, we need to mitigate this by a novel, ecosystem approach, with stakeholders rolling out an end-to-end innovation strategy. Also check out Cell by Design®, the cloud-based software which streamlines ATMP process development in a risk-based and regulatory-friendly way.
According to Jan Schrooten, the integration of in-process monitoring, 4.0 process control supported by machine learning algorithms in a quality-by-design framework are key tools to advance next generation ATMP manufacturing. Many of these technological tools are already part of ATMP innovations that are making their way to the market.
The key message is that robust and end-to-end data collection, using a risk-based approach, is paramount. Only this way can we learn to understand and control the process and product inside-out, make informed, data-driven decisions accordingly, and deliver a high-quality therapy to the patient.
The interactive discussion that followed also touched on regulatory validation of these novel processes. The conclusion was that a robust framework, such as quality-by-design, can support process validation. Moreover, authorities and regulators are key stakeholders to get actively involved in the discussion early on to ensure patient safety but at the same time enable a sustainable route for ATMP developers.
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