Cell Therapy Manufacturing
Advancing Cellular Therapy Product Manufacturing
A major obstacle to stem cell therapy and stem cell research is translating successful research into scalable, sustainable and affordable therapeutics. Other barriers are ensuring the long-term commercial viability of their cellular therapy products, developing scalable, robust, cost-effective cell culture systems, and ensuring that cGMP, documentation and regulatory requirements are strictly adhered to.
Pharmaceutical and biomedical researchers working on the front lines of stem cell science and translational medicine need a partner with a proven track record of advancing cellular therapy product manufacturing: One with optimized bioproduction platforms, purification and characterization tools, and the process development services required to tackle the bottlenecks of autologous and allogeneic cell therapy commercialization.
Adoptive immunotherapies are currently dominating the gene therapy space. Through our SAFC BioReliance offering
we provide world-class process development and manufacturing capabilities for virus based therapeutic products (e.g. gene therapy and viral vaccines).
Process Design for Cell Growth and Harvest
Successfully designing manufacturing processes for adherent cells (e.g., mesenchymal stem cells) in single-use bioreactors is essential for scale-up. Stem cells can now be grown and harvested from microcarriers adequately agitated in bioreactors with proven efficiency and reproducibility.
Cell Culture Media and Reagents
Manufacturers must ensure a safe and sustainable supply of their cell therapy product lines. Both small- and large-scale production and media platforms, including serum-containing media, xeno-free media and serum-free conditions are available for this purpose.
Product Quality Assessment
Stem cell manufacturers must also verify that the expanded and harvested cells maintain their critical quality attributes. Biomarker assays such as ELISAs, RIAs and the MILLIPLEX® Multiplex assays using Luminex® are properly utilized for that purpose. Flow cytometry systems are also used to analyze the quality and potency of stem cells.