Developing Affordable Advanced Therapies: The Role of Cell Culture Media
An interview with Erik Vaessen, head of sales and marketing – industrial cell culture and cell therapy at Fujifilm Irvine Scientific
What’s the key to developing integrated, efficient and automated workflow solutions for cell therapy manufacturing?
Developing towards simplicity and automation. Automation has the potential to address many of the manufacturing issues that prevent efficient, large-scale production and commercialisation of cell and gene therapies. Simplicity and flexibility are also critical factors in improving efficiency and reducing costs.
Currently, there are a lot of steps in most cell therapy manufacturing processes. Reducing steps through improved technologies and automation would improve efficiency and workflow. Flexibility has to be accommodated as well. Each therapy has individual requirements so end-to-end solutions must support the variability in protocols and equipment. We built our custom media development and manufacturing services to provide efficient, flexible solutions for automation.
Developing integrated, flexible, media solutions and protocols that are optimised to work together seamlessly another way we are working towards meeting these requirements.
Can you give us some insight into the future impact of high-performing cell culture media formulations?
Cell culture media is widely considered to be the most important factor in cell culture technology for advanced therapies for many reasons. The media contains nutrients, growth factors, hormones and helps control pH and osmotic pressure. Media can be designed to push the cells to grow in number or to push the cells to differentiate to more mature cell types depending on the application. Media that contain undefined components or serum can cause undesirable effects on cells via the same mechanisms. These reasons are why high-performance, chemically defined media are essential to the future of advanced therapies.
“I predict as regulations mature in this field, the use of chemically defined media will become increasingly important.”
Using a chemically defined medium provides more control and consistency in therapy production. It also reduces the risk of introducing unknown and undesirable components to a patient. I predict as regulations mature in this field, the use of chemically defined media will become increasingly important.
How can the industry work collectively to reduce COGs and develop affordable cell therapies that can benefit patients globally?
I think the industry recognises that COGs must be reduced to bring much-needed therapies to patients globally, and everyone is working closely together on solutions. There is a broad spectrum of challenges that must be addressed—scale-up, automation, release testing, logistics, and regulatory guidelines, to name a few. We can contribute to reducing COGs by increasing manufacturing yields, decreasing manufacturing timeframes and reducing quality control testing costs. We can also cut costs by simplifying the manufacturing process and enabling automation, thereby decreasing labour costs and reducing the lot failure rate.
Many in the industry are also moving to allogeneic, off the shelf therapies, which would also reduce costs compared to autologous therapies because allogeneic lot sizes are much larger. In contrast, autologous therapies, which are based on the one-patient one-batch model, are expensive because the lot sizes are smaller and the process is less efficient. QC testing for autologous therapies is also more costly than allogeneic therapies because the QC testing costs are spread out over a small lot size.
What’s your take on the current advanced therapies manufacturing capacity challenge and how will the industry adapt?
Capacity is a challenge due to a number of reasons. Innovative technology solutions that increase yield while maintaining as small a footprint as possible will help address this challenge.
Look at viral vector production as an example. Manufacturers face challenges in meeting the demand for viral vector production to meet the growing needs of gene and viral vaccine therapies. Problems range from adapting from adherent to suspension models to increase production to sourcing affordable GMP–grade raw materials to meet regulatory guidelines. Continuous manufacturing of viral vectors in a suspension system is an example of how innovative technology will help meet crucial needs for the supply of viral vectors.
Certainly, moving towards allogeneic therapies is another way. These are more easily scaled up to large batch sizes enabling more cost-effective commercial production. Imagine how off-the-shelf cells could transform the industry.
Collaborative partnerships are crucial to progress and innovate in our industry, how do you work with your customers to identify and eliminate their manufacturing and development bottlenecks?
We start every collaboration with a ‘voice of customer’ exercise where our experts work closely with customers to understand their unmet needs to design a customised and individual solution to meet their specifications.
We provide extensive media optimisation and development services paired with flexible manufacturing solutions to ensure customers get the right solution at each phase of development. We view our relationship with customers as a partnership with open, honest communication during the whole process and they have direct interaction with our highly skilled R&D and application scientists.
Regulatory approvals are a big hurdle to overcome in commercialisation. Our regulatory experts are part of this custom solution process and can provide advice and documentation that will help smooth the path to meeting regulatory requirements.
We also feel it is essential to work closely with thought leaders and consortium teams to participate in, and help drive, industry-wide advancements and solutions. By developing cutting edge media formulations that support and enable more efficient production of therapies, we can help advance the field. Our regulatory team also works closely with governing bodies around the world to both understand and help develop guidelines for advanced therapies.
About Erik Vaessen, PhD:
In his role as Head of Global Sales and Marketing, FUJIFILM Irvine Scientific, Erik Vaessen manages commercial operations and oversees business strategy for the bioproduction, cell and gene therapy, cytogenetics, and discovery research markets.
Vaessen joined FUJIFILM Irvine Scientific in 2009, where he has applied 20 years of experience in the life sciences industry within a variety of commercial roles with increasing responsibility. In 2018, Vaessen began overseeing the cell and gene therapy product line, where he built-out a customer-centric approach designed to accelerate cell therapy time-to-market.
Prior to joining FUJIFILM Irvine Scientific, Vaessen held advanced roles with Thermo Fisher Scientific and Sigma Aldrich. He graduated from Wageningen University in the Netherlands, where he studied Molecular Biology and received his PhD degree in Biochemistry from the University of Fribourg in Switzerland. Vaessen and his family currently reside in Rotterdam, the Netherlands.