FUJIFILM Biosciences首席商务官谈细胞与基因疗法规模化生产挑战

Cell and gene therapies are moving beyond small patient populations, but manufacturing remains a major obstacle to wider access. High production costs, complex workflows, and the challenge of maintaining consistency at scale continue to complicate commercialization.

Erik Vaessen, Chief Business Officer at FUJIFILM Biosciences, discusses how approaches to manufacturing have changed, the importance of early process development, and the technologies that could shape the next generation of advanced therapies.

Could you tell us about your role at FUJIFILM Biosciences and what first drew you to bioprocessing?

As Chief Business Officer, I am responsible for our global sales and marketing teams, which help define the strategic direction for FUJIFILM Biosciences. Together, we support a broad portfolio of products and specialist services that enable research and help bring new medicines to patients.

Looking back on my career, I’ve always been fascinated by the science and technology that enable scientists to develop entirely new classes of therapies, with the potential to fundamentally change how we treat disease and improve health outcomes. It is rewarding to see firsthand how far bioprocessing has evolved and the progress the field continues to make.

What are the biggest challenges facing developers as they try to scale bioproduction for cell and gene therapies?

One of the biggest challenges remains the cost of goods – an issue that affects the industry broadly but is particularly apparent when combined with the specific issues facing cell and gene therapy.

Emerging modalities are introducing new complexities for cell and gene therapy manufacturing. As developers move from treating small patient populations to supplying larger numbers of doses, maintaining consistent product quality becomes increasingly difficult. Ensuring that every batch meets the same potency, safety, and efficacy standards while scaling production is a significant manufacturing challenge, particularly given the inherent variability of biological systems.

These factors, combined with the need for efficient, scalable processes and continued reliance on highly specialized labor, represent major headwinds for cell and gene therapy developers working to commercialize therapies at scale.

How has the industry's approach to manufacturing scale-up changed over the past decade?

Historically, many organizations focused on proving clinical feasibility as the first step in development. This has changed dramatically when we look at today’s therapeutic landscape, with many developers now prioritizing scalability, manufacturability, supply chain robustness, and commercial viability much earlier.

It is vital to the success of advanced therapies to begin with the end in mind and consider all aspects of development early.

Which recent innovations are making the biggest difference to manufacturing efficiency?

Unlike many established biopharmaceutical manufacturing processes, cell and gene therapy production still relies on complex workflows, manual operations, and specialized expertise. Some of the most valuable innovations are therefore those that remove complexity and streamline manufacturing operations.

In my view, recent advances in cell culture media and process development have delivered some of the most valuable improvements in biopharmaceutical manufacturing. Innovations in media formulations and culture processes allow developers to optimize cell growth and productivity while maintaining consistency at both small and large scales.

Ultimately, the innovations with the greatest impact will be those that make commercial manufacturing more robust, reduce process complexity, and improve production efficiency with advanced media formulations that can help accelerate the path from development to patient access.

What do developers often underestimate when moving from process development to commercial-scale manufacturing?

The complexity of technology transfer and the amount of human interaction required throughout manufacturing are often overlooked.

Many developers assume that a successful process at development scale can simply be replicated commercially. However, technology transfer, process reproducibility, operator training, raw material variability, documentation requirements, and GMP execution all introduce additional challenges.

To succeed, transferability needs to be considered from the beginning of process design. Early preparation can alleviate many of the challenges that arise during scale-up.

What still needs to happen before cell and gene therapies become more affordable and widely accessible?

Improving the efficacy of cells and viral vectors will be essential. More effective therapies can be administered at lower doses, reducing manufacturing complexity and improving process productivity. This can help lower the cost of goods, which remains one of the most prohibitive challenges facing developers.

Embracing automation will also be a defining factor in the sector's long-term success. As we move from small patient cohorts toward more mainstream treatments, automated processes will become essential for mitigating costs while maintaining the quality and consistency required for commercial products in a tightly regulated industry.

More broadly, we need to ensure a reliable supply chain is in place to support large-scale manufacturing. Cell culture media, buffers, and reagents must be readily available in the appropriate volumes, formats, and configurations. Crucially, supply chains must maintain consistent quality throughout development and scale-up.

Looking ahead, which manufacturing trends will have the biggest impact on cell and gene therapies?

While artificial intelligence, automation, and digital manufacturing will undoubtedly play important roles, I believe some of the most significant trends will be the emergence of fundamentally different manufacturing strategies necessitated by new therapeutic innovations.

For example, we are seeing growing interest in in vivo cell and gene therapies, including in vivo CAR-T and self-amplifying RNA (saRNA) technologies. These approaches have the potential to shift parts of the manufacturing process from conventional, centralized cell-processing facilities to more scalable biologics and nucleic acid manufacturing platforms, helping reduce the costs and logistical challenges often associated with ex vivo therapies.

At the same time, there will be a continued focus on manufacturing robustness, reproducibility, and scalability across advanced therapy development. Investment in process development, cell culture media, raw materials, automation, and analytical technologies will be crucial to building more efficient and reliable manufacturing processes.

Despite recent fluctuations in market investment, the pace of innovation remains strong. Continued development of both ex vivo and in vivo approaches demonstrates how rapidly the field is evolving, creating new opportunities to expand patient access to transformative therapies.

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