ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey Investment Partners, today announced that in partnership with PBL, it developed an enclosed, fully automated cell factory device, the Cell Factory Box (CF Box). This innovative, new device enables decentralized manufacturing of all types of Cell & Gene Therapies (CAGT) in Class D (ISO8) or c.n.c. surrounding areas.

The CF Box uses already-approved AI technology and extensive automation to dramatically reduce manual operation and the need for high-class clean rooms. Additionally, the CF Box uses approved AI technology, and batches detect recognition, which is set to a frozen state during validation and batch manufacturing. Modules can be selected according to individual needs and the type of products/technologies desired, and additional modules can be added at later stages. Robotic arms, cameras, liquid transfer systems, conveyor belts, components, and tools are available in the market, enabling full automation, including but not limited to alerting the operator once the culture has reached the desired values. This flexible solution automates manual processes, supporting diverse manufacturing tasks. It's programmable for various processes, including optimized cell culture expansion and streamlining manufacturing timelines effectively. The CF Box is a flexible solution that allows for the complete automation of different manual manufacturing processes simultaneously.

Eleonora Casucci, Vice President of Quality & Compliance EU at ProPharma, emphasized the importance of this partnership in helping CAGTs address unmet needs. “Regarding treatment options, many are adopting a decentralized approach to manufacturing CAGTs. The CF Box provides key advantages compared to the devices currently available. Our collaboration with PBL positions us to serve those in the CAGT segment fully,” she said.

CAGT is the fastest-growing segment in the life sciences industry and is expected to hit around USD 42.56 billion by 2030. Two primary factors drive this growth: 1) treatment options that small and large molecules cannot offer, and 2) the prospect of providing lifesaving treatments in therapeutic areas where competitor therapies can only provide solutions to extend life expectancy and quality. While CAGTs are often regulatory fast-tracked because they offer groundbreaking treatment options to address unmet medical needs, they also come with complexities that lead to challenges, especially in the regulatory and technical areas.

ProPharma and PBL joined forces to address these challenges with the development of the CF Box to reshape the CAGT market by providing a solution to the excessive costs and limits on access to resources in decentralized manufacturing. As the only device of its kind in the market, the CF Box is a unique and cohesive solution that combines state-of-the-art equipment and world-class services. CAGT services are in high demand, and securing and maintaining in-house, such a wide array of expert skills can be challenging and financially demanding. The main difference between this and alternative options is that ProPharma specialists have deep knowledge of not only the CF Box but also the CAGT market and trends and are positioned to provide flexible and cost-effective support to ensure that more CAGTs reach patients.

“We are honored to work with ProPharma on such a monumental effort,” said Filippo Begarani, Research and Innovation Manager of PBL. “Our first goal is always to conceive, design, and implement technologically advanced solutions with the highest standards of quality and innovation, and the CF Box device will not only change but elevate how CAGTs are manufactured since it supports high reproducibility of the process at various locations.”

Demonstrations of the CF Box will be available at ACHEMA in Frankfurt, Germany, June 10-14, 2024, and upon request after the event in PBL’s facility in Parma, Italy.

About ProPharma

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. For more information about ProPharma, please visit: https://www.propharmagroup.com.

About PBL

PBL was established as an industry-leading custom solutions provider to global pharmaceutical, chemical, and diagnostic corporations. PBL is one of the founding members of the National Center for Gene Therapy and Drugs based on RNA Technology, founded by the Italian Government to support research on the development and manufacturing of CAGTs. PBL is based in Parma, in the heart of the Packaging Valley, the district of advanced mechanics and industrial automation in Emilia-Romagna, Italy. For more information about PBL, please visit: https://www.pbl.it/.