ProPharma and PBL Launch Manufacturing Device for Cell and Gene Therapies

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In partnership with Italy-based PBL, a custom solutions provider to the pharmaceutical, chemical, and diagnostics industries, ProPharma, a US-headquartered provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, has launched the Cell Factory Box (CF Box), an enclosed, fully automated cell factory device. This device enables the decentralized manufacturing of all types of cell and gene therapies (CGTs) in Class D (ISO8) or controlled not classified surrounding areas, according to a May 2, 2024 press release.

“Regarding treatment options, many are adopting a decentralized approach to manufacturing [CGTs],” said Eleonora Casucci, vice-president of Quality & Compliance EU, ProPharma, in the press release. “The CF Box provides key advantages compared to the devices currently available. Our collaboration with PBL positions us to serve those in the [CGT] segment fully.”

According to the release, the CF Box uses already-approved artificial intelligence (AI) technology and is extensively automated, allowing it to significantly reduce manual operation. The nature of the device also reduces the need for high-class clean rooms. Using approved AI technology, the CF Box employs batch detection recognition, which is set to a frozen state during validation, and batch manufacturing. Users can select modules based on individual needs and select the type of products/technologies desired. Additional modules can also 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,” the press release states. The design allows for flexibility in automating manual processes and supports diverse manufacturing tasks. The CF Box is also programmable for various processes, including optimized cell culture expansion, and streamlining manufacturing timelines effectively, according to the release.

“We are honored to work with ProPharma on such a monumental effort,” said Filippo Begarani, Research and Innovation manager, PBL, in the press release. “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 [CGTs] are manufactured since it supports high reproducibility of the process at various locations.”

The CF Box will be demonstrated in Frankfurt, Germany, during ACHEMA, which will be held June 10–14, 2024. PBL is also offering demonstrations after the event and upon request at its facility in Parma, Italy.

The global CGT market size is projected to grow to $82.24 billion by 2032 from $15.46 billion in 2022, with a compound annual growth rate of 18.3% (1). Key market drivers are the exponential increase in the CGT clinical pipeline and an increase in the number of regulatory approvals for innovative medicines.

Reference

1. Precedence Research. Cell and Gene Therapy Market (By Therapy Type: Cell Therapy and Gene Therapy; By Indication: Cardiovascular Disease, Cancer, Genetic Disorders, Infectious Diseases, Neurological Disorders; By Delivery Method: In-Vivo and Ex-Vivo; By End-Users: Hospitals, Cancer Care Centers, Wound Care Centers, Others)—Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2032. Market Research Report, November 2022.

Source: ProPharma