Cell Therapy is the administration of engineered, living human cells, to treat and heal diseases such as cancer.

For CAR-T therapy immune cells (T-cells) are isolated from the blood, genetically engineered to carry a chimeric antigen receptor (CAR) on the membrane, expanded, and finally administered back into patients’ bloodstream. 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 costs. Current production concepts need transformation to increase capacity substantially and meet upcoming demand.

Potentials

  • hope for patients who lack alternatives
  • unique, potentially curative response to cancer
  • extend cell therapies beyond oncology to treat metabolic or neurologic diseases

Challenges

  • high lot-to-lot variability of patient-derived starting materials
  • complex and largely manual manufacturing
  • long process times
  • difficult supply and logistics

7

CAR-T therapies are approved for commercial use

Source

1400

CAR-T clinical trials are conducted globally

Source

40%

of current clinical cell therapy trials target diseases beyond blood cancer

Source

Sarcura's Solution

Sarcura wants to make these life-saving treatments available, affordable, and safe for many patients by developing new and innovative manufacturing systems.

Automation

Robust and reliable automation eliminates manual operation and documentation steps. Increasing the process quality and enabling scalability is absolutely key to industrialising pharmaceutical cell manufacturing.

 

Miniaturization

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 the cellular level.

Integration

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.

Modularity

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.

Benefits

To manage the high variability of starting materials, integrated on-chip analytical technologies will prepare the ground for adaptive cell manufacturing.

Improve Quality

Integrated process and quality control on the cellular level provide real-time process information

 

Reduce Cost

Closed automated system with integrated process and quality control reduce operating and infrastructure time and cost

Increase Capacity

Industrial automation and the elimination of manual interaction enable scalability and increase output

 

Gain Control

Data-based control regimes ensure reliability and reproducibility