What are the most significant recent breakthroughs in cell and gene therapy and how is Thermo Fisher Scientific involved in these advancements?

In 2024, the global landscape of cell and gene therapy (CGT) is marked by significant advancements, with the US FDA and EMEA approving ten new therapies. Nearly 1,900 clinical trials are underway, half of which are in the Asia Pacific (APAC) region. These advancements are driving improved patient outcomes across solid tumor indications, sickle cell disease, beta-thalassemia, and CAR-T therapies for earlier lines of treatment, including a first-line approval for high-risk large B-cell lymphoma.

These global trends are mirrored in key APAC markets, particularly Japan and India, which are leading the way in innovative and cost-effective approaches to advanced therapies. In India, the first homegrown CAR-T therapy was manufactured at a fraction of the cost of U.S. products, approximately a tenth of international prices. This breakthrough highlights India’s potential to make cutting-edge treatments more accessible and affordable. Meanwhile, Japan has marked a significant milestone with the approval of the first-ever allogenic corneal endothelial cell therapy for bullous keratopathy. This approval underscores Japan’s leadership in pioneering advanced therapeutic options and expanding access to transformative treatments. In Singapore, the government subsidised up to 75% of the treatment cost of approved cell, tissue, and gene therapy product (CTGTP) (capped at $150,000) for eligible citizens, to increase patient affordability and market access.

Emerging technologies such as non-viral delivery vehicles and novel gene editing approaches are shaping the landscape of new early-phase trials, with an aim to enhance the therapeutic safety, potency, and accessibility of treatments while expanding the types of rare diseases to target. Rapid CAR-T and smart CAR-T cells are examples of the next-generation therapies that can potentially benefit more cancer patients than ever before. Therapy developers are also pivoting towards allogenic products development using NK cells or iPSC derivatives for cost-effective manufacturing and economics of scale.

How Thermo Fisher is enabling and accelerating these advancements.

At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner, and safer. We continue to strengthen our position in the CGT sector through strategic investments, innovative solutions, and comprehensive services. Our approach is multifaceted, encompassing global facility expansions, substantial R&D investments, and deep customer partnerships to ensure end-to-end workflow optimization.

We recognize that the CGT landscape demands scalable, compliant, and reproducible solutions. That’s why we provide GMP-manufactured reagents, advanced instrumentation, and integrated software solutions designed to streamline manufacturing and accelerate therapeutic development. Our Gibco Cell Therapy Systems (CTS) media and reagents, instruments, and viral vector systems are used in clinical trials and commercialized products across the region.  Our recent innovations, including closed and modular manufacturing systems, are tailored to enhance efficiency, reduce cleanroom time, and drive cost-effectiveness—critical factors in the scale-up of advanced therapies.

Moreover, our sequencing technologies, play a key role in donor and cell bank screening, particularly in allogeneic production. By continuously evolving our offerings and aligning with the latest scientific and regulatory advancements, we are not only supporting our customers but also shaping the future of CGT development on a global scale

Cell and gene therapies are complex to manufacture. Could you share more about the barriers could be addressed?

Cell and gene therapies (CGT) present manufacturing challenges due to the inherent variability in donor-derived cells, impacting the quality of the final product. To address this, the industry is moving towards allogenic products, which not only enables the use of more consistent donor sources but also simplifies the translation of manufacturing platforms and principles across multiple pipelines. Additionally, cutting-edge technologies and processes adopted by clinical-stage biotech companies may originate from academic groups, often utilizing research-use-only (RUO) reagents and manual methods. These factors can make it difficult to qualify and adapt these processes to cleanroom settings, posing significant hurdles for regulatory approval. There is also a critical talent gap at every level of seniority, from lab technicians and engineers to manufacturers and quality personnels in the CGT space. The scarcity of skilled expertise has led to demands in automation solutions and workforce development programs.

Enabling CGT Advancement: Scalable Solutions, Regulatory Support and Talent Enablement

As a leader in the cell and gene therapy space, we recognize the significant barriers developers face and are continuously evolving our solutions to help overcome these challenges. By anticipating needs and providing innovative tools, services, and expertise, we empower customers to accelerate their journey from discovery to delivery, advancing life-changing therapies for patients worldwide.

The closed, automated benchtop systems help standardize processes, improve manufacturing robustness and reproducibility, while modularity empowers users with flexibility and a higher degree of control over each processing step in a workflow. This design philosophy allows us to help developers adapt to the growing demands for flexibility in personalized medicine, applying our systems for various therapies, including but not limited to CAR-T therapies.

The fit-for-purpose CTS reagents for cell culture, gene editing, and viral vector development are GMP manufactured, safety tested and backed by regulatory documentation to support developers in their transition from discovery through clinical and commercial manufacturing.

The rapid safety testing assays, such as qPCR-based mycoplasma and sterility testing, deliver quick turnaround times, enabling timely production decisions.

Importantly, we support developers with readily available protocols and trainings through collaboration programs to help accelerate the integration of our solutions into their pipelines, ultimately to help bring their therapies to market faster. 

Additionally, partnerships with institutes like Biologics Center for Research and Training (BCRET) and Shibaura Institute of Technology - BioDesign Center (SIT-BDC), along with a regional network of CGT lab facilities for hands-on training and workshops, have been established to ensure comprehensive support at every development stage while also contributing to CGT workforce skills development.

Can you provide insights on how Thermo Fisher is collaborating across translational institutes and companies to drive the development of cutting-edge therapies?

Since the inception of our CGT collaboration program in 2022, we have actively partnered with leading translational institutes and companies to advance the development of cutting-edge therapies. Our R&D capabilities and collaboration labs in Carlsbad and Singapore have initiated at least 16 collaborations across the Asia-Pacific and Japan (APJ) region, reflecting the growing demand for innovative solutions.

Our collaboration sites are equipped with specialized capabilities, including process optimization, development, and training using actual human blood-derived samples such as frozen leukopaks. These partnerships facilitate valuable knowledge transfer, provide access to platform SOPs, accelerate the development of proprietary platforms with robust protocols, offer regulatory support, and connect our partners to a global network of scientists and expertise.

In addition to these collaborations, our Customer Experience Centers (CEC) across the region serve as hubs for hands-on workshops, scientist-to-scientist demonstrations, and seminars. These centers are designed to engage both collaborators and aspiring developers, enabling them to experience and explore the possibilities with our comprehensive solutions. This holistic approach ensures that we are not only advancing therapeutic development but also fostering a vibrant ecosystem of innovation.

How is Thermo Fisher supporting developers in navigating the diverse regulatory environments across APJ and accelerating their journey toward patient treatment?

Navigating the diverse regulatory environments across APJ presents several challenges for CGT developers. However, there are opportunities through enhanced communication and collaboration among suppliers, health authorities, and drug manufacturers, and the promotion of regulatory reliance.

We empower developers with a comprehensive portfolio of GMP manufactured, well-characterized ancillary and critical starting materials, complemented by advanced closed-system equipment designed specifically for CGT manufacturing. Our materials undergo rigorous testing to meet precise specifications and adhere to stringent international regulatory standards.

We provide GMP-manufactured media and reagents that are safety tested and supported by comprehensive regulatory and traceability documentation. This reduces regulatory complexities and facilitates a seamless transition from research to GMP-compliant manufacturing environments.

The ancillary materials and equipment are supported by detailed regulatory documentation. By actively contributing to ISO committees and continuously monitoring the evolving regulatory landscape, our solutions remain cutting-edge, safe, and fully aligned with global compliance standards.

Beyond products, we drive thought leadership through whitepapers, educational articles, and strategic partnerships, offering guidance that accelerates the progression from research to clinical trials.  We support customers in advancing CGT therapies, helping them deliver treatments to patients faster and more efficiently.

What forward-looking strategies is Thermo Fisher prioritizing to ensure continued innovation and leadership in the cell and gene therapy industry?

Our long-term vision for continued leadership and innovation in the CGT space is rooted in our unwavering commitment to advancing transformative science, delivering patient-centric solutions, and fostering strategic partnerships.

Accelerating Scientific Innovation: Accelerating scientific innovation is at the core of our commitment to advancing CGT. We are driving standardization across the field through a suite of closed, automated solutions that not only integrate seamlessly at the physical level but also digitally, using tools like Gibco™CTS™ Cellmation software.

In addition, we are leveraging the transformative potential of AI and machine learning to enhance research and product qualification processes. For example, the Invitrogen™  Attune™ CytPix™ Flow Cytometer cell imaging software enables deeper insights into cell function, paving the way for more precise and efficient therapeutic development. These innovations exemplify our dedication to setting new benchmarks in CGT, ensuring that we continue to lead with impactful, cutting-edge solutions.

Scalability and a culture of excellence: By increasing cross-border partnerships and strengthening our internal CGT capabilities across APJ offices, we ensure access to robust technical expertise that drives innovation and operational efficiency.

Equally, we recognize that the foundation of excellence lies in a skilled and empowered workforce. To that end, we are committed to workforce development through expanded training opportunities, working in collaboration with both current and emerging partner institutes. These efforts not only enhance our scalability but also cultivate a culture of continuous learning and innovation, ensuring we remain at the forefront of the CGT space.