Launched in 2021 with funding from Vinnova, the Swedish Innovation Agency, IndiCell aims to ramp up the capacity to develop advanced therapeutic medicinal products (ATMPs) in Sweden. These treatments, including cell and gene therapies, have the potential to cure, treat, or alleviate illnesses like cancer, Parkinson's disease, and diabetes. The goal is to make manufacturing these new treatments easier and ensure their availability to patients.
To do this, project leaders are creating a framework to produce advanced therapies from induced pluripotent stem cells (iPSCs), special cells reprogrammed from skin or blood cells to a stem cell state. These iPSC can differentiate into all cell types of the body, making them a perfect starting material for any cell therapy, and reducing the cost and time needed to produce them.
The initiative aims to establish sustainable processes that can be reused to develop treatments for other diseases in the future. This will be done through two prototype projects: generating dopamine neurons from iPSCs to treat Parkinson's Disease and generating retina cells from iPSCs to treat macular degeneration. The idea is that future projects focusing on different health conditions and cell types will easily fit into the framework established by these model projects.
Navigating the Path to Clinical Impact
Currently, the process of creating cell therapies and bringing them to market poses significant challenges. Through a collaborative alliance involving researchers, healthcare professionals, and industry experts, IndiCell is navigating this complex journey in Sweden.
Anna Falk, professor from Lund Stem Cell Center at Lund University and scientific project leader within IndiCell, explains, "We have created a unique ecosystem that combines academic expertise and industrial know-how. This is helping us to break down barriers and leverage our strengths to achieve common goals, enabling us to progress from research to real-world applications that can impact patients' lives."
The hope is that the project's success in overcoming current barriers will spark the creation of new companies and technologies, strengthening Sweden's position as a hub for these innovative therapies and advancing the field forward.
“IndiCell is helping to provide the big picture. It is like looking from a helicopter to see the entire development pipeline,” notes Anna Falk. “We need to collaborate in ways we are not used to. This vantage point allows us to connect stakeholders and clear the path for therapies to reach patients. We are essentially blowing away the clouds, facilitating smoother collaborations, and harmonizing regulatory processes.”
Educating Future Experts
To create new treatments for patients, research must move from laboratory routines to clean room procedures to meet Good Manufacturing Practices (GMP). This transition occurs in a pre-GMP facility, like the one under construction at Lund Stem Cell Center, and in ATMP centers, like those being developed at Skåne University Hospital and Lund University.
While these advanced facilities operate independently of IndiCell, they support the project's goals and require skilled professionals. Recognizing this, IndiCell's leadership is taking proactive steps to address the future needs for education and expertise in cell therapy manufacturing in Sweden.
"We are investigating the training needed for experts at different levels within the development pipeline. Education is key to ensuring that these experts are ready to drive the field forward," notes Elias Uhlin, project manager leading the establishment of the Pre-GMP Facility at Lund Stem Cell Center and partner within IndiCell.
Already, resources have ben allocated within IndiCell to educate the next generation. Three IndiCell PhD students are being trained to go on to become future leaders in the ATMP development field including Ph.D. student Alice Hägg.
A Vision for the Future
Looking ahead, IndiCell imagines a future where personalized cell therapies are widely available. By creating a roadmap for cell therapy development, simplifying the journey for future researchers, and with the help of additional stakeholders, the team intends to make this a reality.
Anna Falk sums it up nicely: "We are writing the guidebook for developing cell therapies, which we hope will make the journey easier to navigate in the future and enable more researchers to turn their discoveries into treatments."
