UK scientists announce breakthrough in stem cell manufacturing
The researchers have created a new stem cell micro-environment which allows for both the self-renewal of cells and then their evolution into heart cells. The material is a hydrogel containing two polymers – an alginate-rich environment which allows proliferation of cells with a chemical switch to render the environment collagen-rich when the cell population is large enough.
The discovery could be a boon for early stage stem cell manufacturing companies that are looking to speed products through early development.
“The savings will be in time and manpower,” lead scientist Kevin Shakesheff told Bio-Pharmareporter.com. “Our material allows the cells to be grown without a major intervention by people through the growth and differentiation stage. It is also possible to automate the cell culture process using our materials.”
Cell therapy is a rapidly developing area of medicine in which stem cells have the potential to repair human tissue and maintain organ function in chronic disease and age-related illnesses. But, according to the scientists, a major problem with translating current successful research into actual products and treatments is how to mass-produce such a complex living material.
“We are particularly interested in pluripotent stem cells – there are two types embryonic stem cells and induced pluripotent stem cells (iPS). These cells are of great interest because they can, at least in theory, form any cell of the body. The iPS cells can be personalized to match the tissue of the patient,” Shakesheff explained.
Both Catalent and Lonza are developing such stem cells, though their work might not be suitable for this advancement.
“We are not currently targeting cell therapies that are on the market – we need to get involved at an earlier stage so that companies use a robust manufacturing process right from the start of their development process,” Shakesheff explained.
There are two distinct phases in the production of stem cell products: proliferation, which involves making enough cells to form large tissue, and differentiation, which turns the basic stem cells into functional cells. The material environment required for these two phases are different, but Shakesheff and his team have developed a single substance that does both jobs.
“Our aim is to help companies at the early stage of manufacturing development. Cell therapies are particularly tricky to manufacture because a cell can take on different phenotypes depending on the exact conditions it experiences throughout the manufacturing process,” he added. “This is a major issue in terms of quality control and regulatory approval of cell therapies. We hope to help companies at the pre-clinical stage so they can develop a scalable manufacturing process that also minimises the costs of goods.”
Although this latest development is more for companies just starting out, Shakesheff predicts it will be used more widely once it hits the market.
“There is a lot of investment in pluripotent stem cells and clinical trials are starting,” he said. “We expect within a decade for many therapies to use this cell type.”
The research, Combined hydrogels that switch human pluripotent stem cells from self-renewal to differentiation, is published in the Proceedings of the National Academy of Sciences (PNAS).
The work was funded by the EPSRC Centre for Innovative Manufacturing for Regenerative Medicine in which the University of Nottingham is a partner.
