For CAR-T therapy immune cells (T-cells) are isolated from the blood, genetically engineered to carry a chimeric antigen receptor (CAR) on the cell membrane, expanded, and finally administered back into patients’ blood stream. These CAR-T cells successfully find, bind, and kill the tumor cells.
Clinical trials have shown huge remission rates, of up to 94%, in severe forms of blood cancer. These results and the approval of the first commercially available CAR-T therapy in 2017 have fed the expectations of patients and industry alike.
More than 1000 clinical trials are currently conducted, and the pipeline is strongly growing. Existing manufacturing technologies not only show limitations in quality and scalability but also lead to high therapy cost. Current production concepts need transformation in order to increase capacity substantially and meet upcoming demands.
Robust and reliable automation eliminates manual operation and documentation steps. Increasing the process quality and enabling scalability is absolutely key to industrialize pharmaceutical cell manufacturing.
Functional modules, incorporated in a closed single-use cartridge, allow customized process layouts and conceptional flexibility to process different cell types and address individual user needs.
Integrated process analytical technologies (PAT) and quality control (QC) steps provide real-time information resulting in deeper process understanding. Sarcura uses established PAT /QC methods packed in novel silicon chips to transform process data into process knowledge boosting product quality.
Semiconductor technology allows the integration of electronic and photonic structures on silicon substrates.
On-Chip functionality embedded in microfluidic structures enables process management down to cellular level.
Integrated process and quality control on cellular level provide real-time process information
Closed automated system with integrated process and quality control reduce operating and infrastructure time and cost
Industrial automation, and elimination of manual interaction enable scalability and increase output
Data based control regimes ensure reliability and reproducibility