Integration May Be the Missing Link in Cell and Gene Therapy Development
Integrated ecosystems could help provide speed, reliability, and scalability across the advanced therapies sector.
Cell and gene therapy innovation continues to accelerate, but scientific breakthroughs alone are not enough to ensure clinical success. Translating promising therapies into scalable products remains difficult, with development pathways often involving multiple institutions, manufacturing partners, and regulatory milestones.
In a recent IBTV x Technology Networks Expert Perspectives episode, Dr. Marion Hitchcock, managing director of the Cell & Gene Therapies Incubator Berlin and R&D strategy and portfolio manager at Bayer, discussed why fragmentation between research, clinical development, and manufacturing has become a major barrier to scalability. Drawing on her experience developing the new Berlin Center for Gene & Cell Therapies, Hitchcock explained how integrated ecosystems could help bring advanced therapies to patients faster.
Cell and gene therapy development bottlenecks
The development of cell and gene therapies typically involves multiple experts spanning academic research labs, translational groups, contract development and manufacturing organizations (CDMOs), GMP facilities, clinical teams, and regulators.
This fragmentation introduces opportunities for miscommunication, process redesign, and delays. Hitchcock believes it's at this handover interface where most of the friction occurs.
“The biggest gap is not innovation any longer. It's integration.” — Dr. Marion Hitchcock.
Gaps also exist between companies, which often guard process development and manufacturing knowledge, even though many programs share similar processes and operations. This results in parallel teams working in non-overlapping disease areas re-solving identical problems, inhibiting the sharing of practical knowledge that could lower costs and accelerate pathways to patients.
Another aspect of cell and gene therapy development that Hitchcock highlighted as a barrier is manufacturing readiness. Many advanced therapies demonstrate promising results in individual studies or small pilot programs; however, commercial success requires scale, consistency, and regulatory compliance.
“Scale readiness really means that you have a repeatable process, that it's not a one-off success on one heroic day but actually that's something that you can do on a day-to-day basis in a predictable, sustainable, compliant way,” said Hitchcock.
The impact of a lack of scale readiness is felt throughout the development chain and can have knock-on effects on the patients waiting for life-saving treatments. A 2025 study examined availability data for 18 advanced therapy medical products (ATMPs) from 23 EU member states. It found that the average availability of the therapies sits at just 26%.
“ATMPs face product-specific challenges in achieving EU-wide availability, including complex manufacturing, distribution, and administration processes,” the researchers concluded.
Towards efforts to address scalability issues, the cell and gene therapy industry is shifting towards “design for manufacturability,” where therapies are designed with manufacturability in mind from the outset. A lack of consideration for manufacturing in early process development can cause costly delays to clinical phases, as a CDMO may need to redevelop the process to ensure compliance.
“From my perspective, the biggest bottleneck is really the manufacturing readiness, where programs often slow down because the handover isn't working out,” Hitchcock stated.
The promise of integrated ecosystems and centers of excellence
Multiple regions globally are now investing in advanced therapy hubs to help overcome the integration and manufacturing challenges the cell and gene therapy industry faces.
By bringing expertise together in a single ecosystem to form centers of excellence, these hubs aim to make it easier for developers to design with scalability in mind by providing access to the right experts early in the decision-making process.
These development hubs can help “front load” cell and gene therapy programs with the competencies and contacts needed for clinical and commercial success. This ensures that potential failure points, such as product-market fit and manufacturing viability, can be addressed earlier, raising the chances of success.
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One such hub is the Berlin Center for Gene & Cell Therapies. The hub brings together an incubator with state-of-the-art laboratories, GMP manufacturing facilities, offices, and communal spaces, to help translate innovative cell and gene therapy research quickly and effectively.
“Co-location is really enabling a smooth handover where the handover actually turns into collaboration because you have everybody integrated in the same environment,” said Hitchcock.
These innovation hubs can provide start-ups and academic spinouts with the access to expertise, infrastructure, and capital they need to bring their breakthrough therapies to clinical trials.
“For example, in our incubator that we will build, we will also have a shared lab for the highest-priced equipment because all these upfront investments are also a huge barrier for companies,” explained Hitchcock. “The same for access to GMP technology. We want to lower those barriers in terms of financial investments.”
The next chapter of cell and gene therapy may be defined less by breakthrough discoveries and more by how effectively the industry connects research, clinical development, and manufacturing into a seamless pathway from laboratory innovation to patient care. Designing for manufacturability and investment in integrated hubs are just some of the ways the industry is adapting to the demand for more scalable advanced therapies.
About the interviewee:
Dr. Marion Hitchcock is the managing director of the Cell & Gene Therapies Incubator Berlin and R&D strategy and portfolio manager at Bayer. She holds a PhD in organic chemistry from Technische Universität Berlin. Hitchcock’s achievements include establishing a successful multi-year research alliance with Johns Hopkins University, bridging the gap between academia and industry to drive advancements from the bench to the bedside.
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