Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

Published on: 

The collaboration addresses the need for risk mitigation plans in cell therapies.

On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that they have entered into an agreement to include 4Tune Engineering’s iRISK platform in Cytiva’s cell therapy product offering.

Cytiva customers in the early stages of cell therapy product development will gain access to these tools, which can identify risks and evaluate and implement structured risk management plans. Cytiva research has shown that 75% of global respondents are actively developing or have a risk management program in place. With early stage development programs approaching commercial launch, some organizations are currently relying on manual processes or reactive mitigation strategies.

The iRISK platform is a fully integrated automated solution that identifies, quantifies, and prioritizes risks. The platform can also formulate risk mitigation strategies for new or existing processes throughout the manufacturing lifecycle. The platform can be customized to meet specific customer needs.

“The manufacture of cell therapies is inherently more risky than traditional biotherapeutics. As we look to improve the manufacturing process, working with 4Tune Engineering to provide our customers with an automated and structured risk management platform is a clear choice. Our customers will have peace of mind knowing they have a strong risk mitigation process in place,” said Catarina Flyborg, vice-president, Cell and Gene Therapy, Cytiva, in a company press release.


“Our collaboration with Cytiva will provide their customers with an automated, systematic, and user-friendly approach to risk management that will improve lifecycle management of cell and gene therapies and business performance of companies involved in that space,” added Marcos Domingues, CEO, 4Tune Engineering, in the press release.

Source: Cytiva