Scalability and manufacturing processes

Scaling manufacturing techniques to meet global demand
The CGT landscape in 2025 continues to expand, offering unprecedented opportunities but also presenting unique challenges. Key among these is the scalability of advanced manufacturing techniques to meet growing global demand. Despite advancements in automation and AI, the high variability of cell types and gene-editing techniques complicates the streamlining of production. Reliable and scalable methods to preserve, transport, and administer delicate cellular products are vital to success. New drug delivery systems like hydrogel encapsulation, essential for targeted and efficient administration of therapies, have the potential to reduce complexity in manufacturing, as well as simplify logistics by obviating the need for cryopreservation. Equally pressing is equitable access. Delivering personalized therapies to patients in underserved regions is hampered by prohibitive costs and the lack of specialized health care infrastructure. Bridging this gap will require innovative delivery models, such as decentralized manufacturing and point-of-care solutions.
• Stella Vnook, CEO, Likarda

Enabling scalable manufacturing with process automation
The advent of advanced therapy medicine, including cell and gene therapies, has created a paradigm shift for the treatment of dozens of indications previously thought to be intractable, both in oncology and rare disease spaces. With hundreds more in the clinical pipeline, a need for better process automation arises to enable scalable manufacturing, as well as cost and complexity reduction. This is paired with the need for enhanced visibility and redundancy in the supply chain and cold chain management. Finally, disruptive technological innovation, such as in vivo gene editing, while holding great promise for patients, exposes our weaknesses from a capability readiness perspective. To fully realize these advancements, we must continue evolving to better serve patient needs.
• Rohin Krishnan Iyer, Senior Director of Cell and Gene Operations, Marken

Understanding manufacturing’s impact on efficacy
Looking ahead to 2025, the cell therapy sector faces complex challenges in both biology and manufacturing. The core challenge lies in understanding how manufacturing conditions affect therapeutic efficacy — particularly how expansion protocols and culture conditions impact cell persistence and functionality post-infusion. While we can grow large numbers of CAR-T cells, maintaining their stemness and preventing exhaustion during manufacturing remains difficult, directly impacting patient outcomes. For iPSC or allogeneic products, preventing immune rejection adds complexity. Product variability presents another significant hurdle. Starting material from different donors produces cells with varying metabolic profiles and capabilities, yet current manufacturing processes aren't adaptive enough to normalize these differences. Emerging solutions like genetic engineering, advanced culture media, and automated manufacturing platforms with real-time monitoring systems show great promise. With continued innovation and collaboration across the sector, we are well-positioned to overcome these challenges and expand the reach of cell therapies to more patients.
• Blythe Duke Sather, Ph.D., VP, Head of Research, Tune Therapeutics 

High costs of manufacturing
The biggest near-term challenge in the cell therapy industry continues to be the high cost of manufacturing doses, particularly with autologous products. Developers will be prioritizing the incorporation of tools and methodologies that align to a scaling strategy that will drive to efficiencies in manufacturing. Adopting new and emerging technologies will be important and the ability to automate complex processes will be critical to drive down costs and meet the demand of larger patient populations. We are accelerating our efforts to bring new technologies to the field that provide a high degree of flexibility and biological precision to cell therapy researchers to support cell isolation, activation and expansion. Additionally, advanced analytics and characterization tools will be required to enable process control and quality monitoring. The goal is to shorten the production workflow, simplify the steps, and provide a rapid path to automation.
• Andy Campbell, Sr. Director, R&D, Thermo Fisher Scientific

Development of a scalable, sustainable and repeatable vein-to-vein process
The greatest challenge facing CGT, particularly in the context of autologous CAR-T therapies, is the development of a scalable, sustainable, repeatable and robust vein-to-vein process. Addressing these issues is essential for the broader success of cell and gene therapies as a whole. Several challenges in scalability and sustainability include a shortage of specialized professionals, as well as high manufacturing costs driven by the complexity of the therapies, labor inputs and QC testing. Additionally, processes often require intensive labor and the use of expensive raw materials, further increasing manufacturing costs. The ability to quickly release products is also limited by constraints in methods, processes and available personnel. In terms of repeatability and robustness, challenges include high variability in donor cells, which can result in unpredictable drug product performance. Processes are often bespoke, requiring expert input to ensure product release. Finally, the logistics of managing time-sensitive cold chain transport adds another layer of complexity to the overall process.
• Edward Ahn, CEO, Medipost

Legacy manufacturing processes
The biggest challenge facing the cell and gene therapy sector in 2025 is legacy manufacturing processes, which remain the leading driver of high therapeutic costs. Because they are complex, resource-intensive, and difficult to scale, legacy manufacturing technologies and approaches create a bottleneck that inflates costs and limits patient access. These inefficiencies not only hinder affordability but also slow the pathway from development to delivery, reducing the potential impact of transformative therapies.

As the demand for CGTs grows, the sector must address this issue head-on. Without significant innovations in manufacturing that enhance production efficiency, the gap between innovation and patient accessibility will continue to widen. Ensuring sustainable manufacturing practices that lower costs without compromising quality is crucial for the future of cell and gene therapy. Overcoming this challenge will determine whether these lifesaving therapies can truly achieve their promise of transforming global health care.
• Igor Fisch, CEO and Founder, NewBiologix

Global accessibility

Making therapies affordable around the world
While the advanced therapy industry has put a stake in the ground demonstrating these medicines can be extraordinarily effective and lifechanging — especially for rare monogenic disorders and blood cancers — to really emerge as first line therapies, we have to focus on global patient access as well.  We’re well beyond the proof-of-concept stage.  A lot of attention has been paid recently to cost of goods, and solutions such as automation and fully closed manufacturing platforms have been proposed and promoted, but we also have to think about simplifying (wherever possible) processes if we ever hope to make therapies affordable around the world. Finally, we have to think about underserved populations that face challenges such as limited access to large clinical centers, and how they might expect to not only receive care, but participate in the trials of new medicines. Here advocacy groups serve the critical function of educating patients, payers and providers.
• Phil Vanek, Chief Technology Officer, Gamma Biosciences

Commercial viability
While gene therapy is compelling from a scientific standpoint, it is proving challenging from a commercial point of view. Given the one-time, extremely high-cost treatment that comes with gene therapy, global mechanisms for pricing and reimbursement struggle to provide an environment to make these therapies commercially viable within the constraints of health care budgets. Whilst multiple global discussions around access and reimbursement for these types of therapy are underway, developers of gene therapies will similarly be determining how and if they can make the innovation commercially viable.
• Fran Brown, Ph.D., Senior Vice President, Certara Drug Development Solutions 

Ensuring global accessibility
In 2025, the biggest challenge for the CGT sector will be ensuring therapies are accessible worldwide. There are several factors at play, starting with the significant capital required to scale up advanced manufacturing technologies. On top of that, unpredictable weather and logistical hurdles make delivering therapies across regions more difficult. The lack of harmonized regulations and differences in infrastructure only add to the complexity. As more countries get involved in CGT, there's a growing push to standardize regulations for smoother multinational clinical trials. This also includes engaging other industry stakeholders and patient advocacy groups. While automation in manufacturing and clinical trial data collection is on the rise and expected by guidelines, it drives up technology costs for new entrants, making it harder for emerging markets. Addressing all of these challenges will be key to making CGT more accessible on a global scale.
• Lisa Kretzschmar, Senior Scientific Advisor, Cell & Gene Therapy, BioIVT

Patient-specific supply chains

Material collection and product administration
I think 2025 will present challenges to the advanced therapy sector because of continued approvals and the increase in the number of commercially available advanced therapies. At TrakCel we are acutely aware of the challenges faced daily by clinical sites, when administering advanced therapies. The proliferation of commercially available advanced therapies will exacerbate the stress and pinch points associated with collection of starting material and drug product administration. To alleviate these problems, the sector should look to technologies that can help simplify activities and unify some aspects across different commercially available therapies. The right platform is crucial to the successful management of data for chain or identity and chain of custody as CGTs are rolled out to approved treatment centers. 
• Matthew Lakelin, Ph.D., Co-Founder & Head of Consultancy, TrakCel

Navigating a patient-specific supply chain
As the cell therapy field navigates the early stages of commercialization, centralized manufacturing by large pharma companies has been the predominant approach. This mirrors the supply chain strategies historically used for small molecules and monoclonal antibodies. However, cell therapy differs fundamentally from these modalities due to its highly patient-centric nature. The process begins with the collection of cells from an individual patient and concludes with the delivery of a customized therapy back to the individual. This patient-specific supply chain introduces unique challenges, including cold-chain maintenance, strict time constraints, and the critical need for end-to-end traceability and chain-of-identity. To address these challenges, the industry will transition over time to fit-for-purpose manufacturing models tailored specifically for cell therapies. Such models will incorporate patient-adjacent, regionalized manufacturing with advanced end-to-end digital logistics. By doing so, manufacturers can better ensure the quality, safety and efficacy of these transformative therapies while enabling scalability and broader patient access.
• Jason Bock, Ph.D., CEO, CTMC

Lack of standardization at clinical sites
It’s something we’ve all heard before, but maybe not in the way you’d expect. A lack of standardization remains a challenge for all facets of cell and gene therapy today but is most acutely felt as a bottleneck in onboarding sites for both clinical trials and offering commercially approved treatments. This is driven by the fact that the industry has largely moved past the point of asking “do these therapies work?” and into “how do we bring these therapies to more eligible patients?” As a solution, the concepts of decentralized and point-of-care manufacturing are being more seriously talked about to increase patient access. However, the processes of site accreditation and contracting can take months — even years for smaller institutions with less internal expertise. As the number of therapies moving through clinical trials increases in 2025, the need for standardization here will be more significant.
• Trevor Smith, Senior Manager, Regional Marketing, Terumo Blood and Cell Technologies

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