Full Breakdown
Advancements in Cell and Gene Therapy Manufacturing Through Strategic Collaborations
11/27/2025, 1:26:14 PM
Collaborative Efforts to Enhance Manufacturing
Bracco Imaging and Limula have initiated a research and development project aimed at improving cell and gene therapy manufacturing. This collaboration, which includes Nicola Vannini, PhD, from the University of Fribourg, Switzerland, seeks to address the manufacturing bottlenecks that hinder the widespread adoption of these therapies. The project, funded by the Swiss Innovation Agency Innosuisse, aims to integrate lipid-based microbubbles with automated cell processing technology to enhance cell selection and activation processes. Vannini emphasized the potential of these innovative approaches to improve patient outcomes, while Thierry Bettinger, PhD, from Bracco, highlighted the significance of this multidisciplinary partnership in advancing cell manufacturing.
Global Regulatory Approvals and Market Dynamics
The gene, cell, and RNA therapy landscape saw significant momentum in the third quarter of 2025, with four global approvals marking key regulatory milestones. Notable approvals included Hrain Biotechnology’s Hicara CAR-T for large B-cell lymphoma in China, and FDA approvals for Precigen’s Papzimeos and Ionis Pharmaceuticals’ Dawnzera. Additionally, ExCellThera’s Zemcelpro received authorization in Europe. Despite a slowdown in trial initiations, the global pipeline remains robust, with over 3,200 active studies. The quarter also witnessed a 9% increase in deal-making activity, indicating a renewed interest in the sector.
Addressing Accessibility Through Strategic Partnerships
A new partnership between Caring Cross and Amrita Research Center Delhi aims to make cell and gene therapies more accessible in India, particularly for underserved communities affected by diseases such as Sickle Cell Disease and Thalassemia. This collaboration seeks to develop affordable and scalable CGT solutions, addressing the high costs that limit access to these transformative therapies. The initiative includes establishing decentralized manufacturing to facilitate the delivery of cures at the point of care, focusing on next-generation therapies like TriCAR-T for leukemia and lymphoma.
Strengthening the UK’s Gene Therapy Manufacturing Pathway
In the UK, eXmoor Pharma and Royal Free London NHS Foundation Trust have formed a strategic collaboration to streamline the development and manufacturing of cell and gene therapies. Announced on November 26, 2025, this partnership aims to reduce complexity and accelerate timelines by aligning technical transfer processes and regulatory expertise. Angela Osborne, Founder & Executive Chair of eXmoor Pharma, noted the importance of connecting early-phase research with long-term manufacturing strategies to enhance the UK’s position in advanced therapeutics.
Criticism and Challenges
Despite these advancements, challenges remain in the field of gene therapy. Many in vivo applications still struggle to effectively target tissues or cells, raising concerns about the efficacy of current delivery methods. Critics argue that while collaborations and innovations are promising, the practical implementation of these therapies must overcome significant hurdles to achieve widespread clinical success.
Verbatim Quotes
- “We see tremendous potential in innovative approaches to some of the key cell manipulation steps required to deliver improved patient outcomes,” — Nicola Vannini, PhD, University of Fribourg
- “This partnership reflects the need for a multidisciplinary approach to innovation in cell and gene therapy.” — Thierry Bettinger, PhD, Bracco Research Center Geneva
- “This collaboration is a powerful example of how the UK’s strength in early research can be matched with long-term manufacturing foresight. CVIC is doing vital work in early-phase GMP, and by connecting that with eXmoor’s development and commercialisation expertise, we can create a clearer, more supportive route to bring promising therapies to patients. It’s about strengthening the UK ecosystem so that innovation stays here and thrives here.” — Angela Osborne, Founder & Executive Chair, eXmoor Pharma
This synthesis highlights the ongoing efforts and collaborations aimed at enhancing the manufacturing processes of cell and gene therapies, while also addressing the challenges and criticisms faced in the field.
