Cell therapy manufacturers need flexible, closed, and automated solutions to support the industry’s growing treatment options and increasing scale.
Treating patients with autologous CAR T therapy, using their own cells as medicine, has opened the door to exciting new possibilities in the fight against cancer. Next in line to push the boundaries of cell therapy even farther are allogeneic formulations, made from a single source of donor cells that can be engineered to treat an entire patient population.
With more than 50 allogeneic cell therapies in the clinical pipeline and steady growth expected over the next 10 years, research and development in this space is bustling — but current manufacturing options are often limited to repurposed technologies that were made for other therapeutic applications. To support future demand, drug manufacturers will need new workflows specifically designed to meet the unique needs of large-scale allogeneic cell therapy production.
The scalability of allogeneic cell therapies can increase access and shorten time to lifesaving treatments
While autologous therapies warrant complex, time consuming, and resource intensive processing to deliver just one patient-specific dose, the ability to scale allogeneic cell therapy manufacturing is a key driver of interest in the scientific community.
Dr. Aaron Dulgar-Tulloch, Cytiva’s Global Head of Research and Development, Cell and Gene Therapy, explains why being able to quickly make batches of cell therapy doses for large patient populations will provide broader access to critical care. “With allogeneic cell therapy, you’re preparing many doses that can essentially sit on a shelf and follow the more classical treatment path of a therapeutic. When a patient has a disease, we can get the drug and administer it in a shorter timeframe. We believe faster, more widespread access to lifesaving treatment will have a positive impact on society’s health.”
Flexible, closed, and automated manufacturing workflows are essential for allogeneic cell therapy production
Recent advances in genetic engineering are driving fast progress in allogeneic cell therapy research. With cell therapy treatment applications expected to expand toward solid tumors and other complex diseases, manufacturing workflows should be designed to keep pace with this dynamic space. “With increasingly complex modifications being studied for cell types beyond CAR T, the ideal workflow will be broadly applicable to a range of allogeneic cell therapies,” says Dulgar-Tulloch. “At Cytiva, we’re working to create modular solutions that manufacturers can modify to accommodate this particularly diverse pipeline without needing a completely new platform.”
Dulgar-Tulloch also sees fully closed and automated systems as key to using space and resources efficiently while adhering to the strict control requirements that come with GMP production. “If a manufacturing platform is fully closed to maintain its own sterility, we can potentially move toward lower grade clean rooms. This infrastructure change would increase the number of therapeutics that can be generated within a given manufacturing space.” Automated systems also help to standardize and monitor critical processes, driving product consistency and reducing the risk of compromised batches due to manual error.
Collaboration can play a key role in bringing an allogeneic cell therapy to market efficiently
Cytiva has partnered with Bayer to merge therapeutic and platform development efforts into one cohesive journey, a move Dulgar-Tulloch says will lead to more efficient delivery of practical solutions to support a growing industry. “To build the best possible workflow for allogeneic cell therapy, we recognized that we needed to find a partner who intimately understands therapeutic development and has the scale, scope, and experience to know what’s needed to bring a drug to market — that’s what led us to Bayer.”
Beyond complementary strengths, Cytiva and Bayer’s partnership is fueled by a shared goal to drive widespread progress. “We have a vision for an end-to-end, fully automated and flexible manufacturing system that’s going to serve the needs of not only Bayer, but the industry as a whole,” Dulgar-Tulloch explains.
Allogeneic cell therapy advances will happen by supporting drug developers big and small
Cytiva’s partnership with Bayer will work to build an allogeneic cell therapy manufacturing platform for large-scale production, but the team recognizes the importance of developing solutions for drug developers at all stages. Dulgar-Tulloch explains, “Part of our focus in building this platform is finding ways we can help translational groups develop their processes more efficiently, so they can seamlessly transition from the hood to a manufacturing workflow as their therapeutic matures.”
Ultimately, it’s going to take a collaborative, end-to-end approach to make the promise of allogeneic cell therapy a reality. Dulgar-Tulloch agrees, adding “If we take lessons learned from other therapeutic areas, it’s not the manufacturing technologies that are going to drive drug development, but new drugs won’t be successful without the manufacturing technologies. So, we want to understand not only what we need, but also what other industry leaders and our competitors think is needed as well. Then, let’s partner and build it.”