Cytiva and 4Tune Engineering to collaborate in quality risk management for cell therapies

  • Strategic collaboration addresses the need for risk mitigation plans in cellular therapies

December 3, 2020

Cytiva, a global life sciences leader, and 4Tune Engineering, a manufacturing-sciences and technology leader, have entered into an agreement to include 4Tune Engineering’s iRISK™ platform as part of Cytiva’s cell therapy product offering. Cytiva customers whose infrastructure is less mature will gain access to the necessary tools to identify risks, evaluate and implement structured risk management plans. According to research conducted by Cytiva, 75 percent of respondents are actively developing or have a risk management program in place. These respondents were globally diverse, at organizations of various sizes and all working in genemodified cell therapies.

iRISK™ platform is a fully integrated automated solution that identifies, quantifies, and prioritizes risks and formulates risk mitigation strategies for new or existing processes throughout the manufacturing lifecycle. Like Cytiva’s flexible product offering, the platform can be customized to meet specific customer needs.

Clinical trial successes have placed many cellular therapies on an accelerated path to market. With early stage development so close to commercial launch, some less mature organizations are relying on manual processes or reactive mitigation strategies.

Catarina Flyborg, Vice President, Cell and Gene Therapy, Cytiva says: “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.”

Marcos Domingues, CEO, 4Tune Engineering says: “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.”

Dr. José C. Menezes, chairman and Founder of 4Tune Engineering says: “We are excited to team up with Cytiva because we share a similar vision about the challenges and solutions required to accelerate the development of advanced therapies (ATMPs) through robust science- and riskbased approaches to serve a very heterogeneous patient population.”

There are currently more than 1,000 regenerative clinical trials underway globally creating an immediate need for strong risk mitigation strategies to ensure patient safety.

Additional Information:

About Cytiva

Cytiva is a global life sciences leader with more than 7,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.

About 4Tune Engineering

Founded in 2004, 4Tune Engineering is a world leading company in Manufacturing-Sciences & Technologies (MS&T), working hand to hand with the world’s most successful companies to improve their performance across the entire Lifecycle chain. Committed to innovation, 4Tune Engineering provides 4.0 Intelligent & Integrated cloud-based solutions to support Pharma and Biopharma Industries’ Digital Transformation. Pioneers with the development of the first Risk Management Platform for Pharma & Biopharma industries, 4Tune Engineering has won international awards with its cloud-based platform iRISK™. Life sciences customers rely on 4Tune Engineering state of the art solutions. With headquarter in Lisbon, Portugal, and offices in São Paulo, Brazil. For more information, visit

Media Contacts:

Colleen Connolly
+ 1 774 245 3893

Daniela Santos
4Tune Engineering
+ 351 216062788

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