Identifying Options For Stem Cell Based Therapy Scale-Up
By Matthieu Egloff, Product Manager and Jose Castillo, Global Cell Culture Director, ATMI LifeSciences
Cell-based therapies are gearing up to have extensive impact on the healthcare field in coming years. With a promise for treating various diseases, and long-term conditions like heart disease and metabolic disorders, stem cell therapies are gaining valid appreciation as a viable alternative to traditional methods. In fact, the overall U.S. market for stem cell products is predicted to reach as much as $6 billion by 2020, according to research from Robin Young Consulting.
In order to capitalize on the potential of these therapies, there must be efficient methods for growing the adherent stem cells necessary for developing subsequent treatments. In the simplest terms, a proper surface is required that enables cell growth and harvest. In the lab phase, the focus is on producing the expected cell without much concern over cost or volume. However, when moving to a larger scale, cost becomes a significant issue, driving the need for manufacturing technology with an emphasis on safety, reproducibility and adherence to GMP standards.
To decipher between manufacturing options, it is important to note whether cells are being grown for autologous or allogeneic therapies. Autologous therapies are based on the patient's own stem cells, so batches remain the same size, however multiple batches must be scaled out. In allogeneic therapies, all patients receive the cells from a donor, so batches are inherently larger and require the process to be scaled up through more surface area. Still, both processes raise practical challenges for the development of a commercially viable manufacturing process.