Optimising T-cell expansion to improve early-stage cell therapy

Maria Knaub, Senior Medical Affairs Operations Lead at Terumo Blood and Cell Technologies (Terumo BCT), brings a unique blend of frontline experience and scientific expertise to the fore of cell therapy innovation. Her background as a paramedic and PhD in cancer biology have led Maria to lead global medical affairs efforts focused on advancing cell and gene therapies (CGTs). Her role centres on external engagement, key opinion leader (KOL) development, and coordination of external scientific studies – crucial functions that ensure Terumo BCT stays aligned with the real-world needs of clinicians, researchers and patients alike.

“I try to bridge the gap between research and patient access,” Maria says, “helping to advance life-saving therapies from bench to bedside.”

Tackling manufacturing bottlenecks through collaboration

In the highly complex and evolving space of early-stage drug development, the path from research to scalable manufacturing is littered with challenges. To address these, Terumo BCT has partnered with Fujifilm Biosciences (previously known as FUJIFILM Irvine Scientific) to deliver a turnkey solution designed to simplify and de-risk the development pipeline for cell therapy companies. 

Many early-stage developers struggle with inconsistent materials and improvised methods, leading to challenges with reproducibility and scalability. Through their collaboration, Terumo BCT and FUJIFILM Biosciences are helping to standardise workflows using validated reagents and cell culture media. By integrating Terumo’s cell expansion system, developers can operate within a unified, consistent platform from research through to good manufacturing practice (GMP) manufacturing.

Enabling standardised T-cell expansion for scalable therapies

T-cell expansion is a pivotal step in the development of CAR T and other T cell-based therapies. To streamline this process, the collaborators have integrated T cell expansion media that is xeno-free into the cell expansion system, creating a robust, standardised protocol that serves as a launchpad for therapy development.

“This provides a good starting point for therapy developers, who otherwise would need to perform initial optimisation steps with their media of choice,” Maria explains. “Instead, they now need only to focus on implementing their unique features.”

This approach not only saves time but also supports a broad range of therapies, offering flexibility and scalability that is often missing in early-stage research. 

Supporting startups with a workflow-ready, cost-efficient approach

For biotech startups and research labs, cost and scalability are big concerns. Often, these innovators must design processes that work in small batches, only to later face challenges when transitioning to GMP standards and clinical-scale manufacturing. This process can be both time consuming and expensive, frequently sending teams back to the drawing board for a rethink.

Terumo BCT’s platform alleviates that burden by offering an immediately scalable solution. With automation and consistency built in, early-stage developers can move forwards confidently without reinventing core processes. The result is lower development costs and a smoother transition from lab to clinic.

Removing barriers in early-stage CGT manufacturing

The cell therapy industry faces ongoing pressure to optimise manufacturing while conserving resources. In the current economic climate, where many companies are navigating limited funding, time and personnel are at a real premium. The solution offered by this collaborative team helps mitigate these issues by reducing the full-time equivalent (FTE) effort and financial investment required to develop a compliant and scalable manufacturing process.

“By offering a standard protocol with our scalable and automated technology, which can be seamlessly implemented in different T cell-based workflows, we can help reduce the cost and FTE-time needed to develop that process – crucial commodities, especially for early-stage companies,” said Maria.

How optimised expansion can accelerate discovery

Looking to the future, optimised cell expansion processes promise to reshape the landscape of drug discovery in immunotherapy and regenerative medicine. More efficient workflows will allow for higher yields, lower costs and reduced use of critical resources, the benefits of which will drive broader access to both autologous and allogeneic therapies.

Streamlined manufacturing also shortens the time between discovery and clinical application, enabling faster initiation of clinical trials and, ultimately, quicker access to therapies for patients in need. Enhanced protocols may also improve the quality and functionality of the expanded cells, leading to better outcomes and more promising avenues for innovation.

As Maria puts it, “Optimised expansion processes will free up resources for additional testing as multiple cell types or genetic modifications, thereby accelerating discovery.”