Draper is developing technology specifically for bioprocessing immunotherapies using innovative approaches, including acoustophoresis, integrated sensing and high-precision microfluidics. Our vision is a closed, modular, end-to-end, benchtop manufacturing system that doctors, researchers and the pharmaceutical industry can use to produce immunotherapies of high quality quickly, safely and cost-effectively. Achieving this will dramatically expand patient access to these treatments.
Researchers at hospitals, academic institutions, and pharmaceutical companies are developing powerful treatments that program immune cells and other cell types to fight diseases such as blood cancer more effectively than conventional methods. Making these immunotherapies is complex, however—a single treatment costs hundreds of thousands of dollars and takes several days to prepare. Most manufacturers use equipment intended for research—ill-suited to large-scale cellular bioprocessing.
Shortcomings of today’s conventional bioprocessing approaches
Inconsistency and Inefficiency:
A large number of cells need to be processed to yield enough therapeutically effective cells for a full treatment because
- 20-40% of conventionally processed cells don’t receive the new genetic instructions
- Some cells are damaged, exhausted or killed during processing (e.g., by centrifugation)
Contamination risks of open-system bioprocessing:
- performing various process steps at separate lab stations
- transferring cells from open containers or from one machine to another
Long Processing Time:
Nationwide, only a handful of processing centers can manufacture CAR T-cell therapies, so patient cells are shipped to them and after processing cells they ship immunotherapy to patients.
- Many processing steps are done manually.
- Some steps take days.
- The entire sequence takes 12-17 days.
- Many patients die waiting for their cells to be processed.
High Costs Limit Accessibility to Patients:
A single CAR T-cell therapy treatment ranges from $350,000-475,000 because
- viral vectors are difficult to manufacture and therefore are expensive.
- conventional processes to introduce viral vector into T cells are inefficient.
- transporting cells back and forth between patient and processing center is costly.
Strategy to Design Better Bioprocessing Technology
To make cell-based immunotherapy broadly available to patients, bioprocessing must produce high-quality therapy quickly and affordably. To accomplish this, bioprocessing must be standardized, scalable to volume production and automated. Draper is developing modular devices for key parts of the bioprocessing pipeline, with the goal of building a complete, end-to-end closed system. The high-precision microfluidics technology Draper is using to design devices is efficient, mass-producible, scalable and cost-effective.
Draper’s solution for cell separation: using sonic waves
Instead of separating immune cells in a patient’s blood by spinning it in a centrifuge, Draper has developed a device that separates them acoustically. In response to sound waves applied to blood/plasma placed in a high-performance microfluidic device, T cells separate from other blood components and move into their own channel in the device, isolating them for collection.
- better removal of interfering white cells
- better end-to-end yield of T-cells, especially in patients with low T cell counts
- continuous flow
- less handling and faster delivery to next steps in the process
Draper’s solutions for gene delivery in cells:
Viral transduction is the gold standard for gene delivery in T cells for CAR T-cell therapy, and Draper has developed technology to increase its speed and efficiency. Instead of putting activated T-cells into a petri dish with viral vector or centrifuging them with viral vector, Draper’s microfluidic transduction devices uses gentle, controlled fluid flow to concentrate viral vector around cells, increasing viral-cell interaction.
- uses about half the viral vector that other techniques do to get high transduction efficiency
- is closed and sterile and can be connected in-line to the cell separation technology
- integrates easily into existing lab automation systems for generating CAR T-cells
Transfection introduces RNA or DNA into a cell, with functions that range from deletion of an undesirable gene to insertion of a therapeutic gene (such as a CAR), without using viral vector. Electroporation exposes cells to electrical current, making their membranes temporarily permeable. Traditionally used in research, most commercial electroporators process cells in small batches with low yields of usable cells. To make electrotransfection practical for clinical-scale cell therapy production, Draper has engineered a continuous-flow electroporation device; it uses high-precision microfluidics to tightly control electrical current exposure, increase throughput and reduce the manual touch labor compared to conventional batch electroporation.
- increases efficiency of cell modification
- minimizes cell death from the procedure
- inserts genes in seconds rather than hours
- processes enough cells for a therapy within eight hours, rather than several days
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