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Wednesday, July 19, 2017

Draper Brings Scalability to CAR T-Cell Bioprocessing

Company’s microfluidic system designed for new cell therapies 

CAMBRIDGE, MA – A pioneering new kind of cancer therapy that uses genetically engineered cells from a patient’s immune system has a very bright future following studies that show 83 percent of patients in clinical trials had their cancer go into remission. A U.S. Food and Drug Administration panel agreed and unanimously endorsed the treatment, called tisagenlecleucel, for FDA approval. However, the FDA did note “a major consideration for manufacturing tisagenlecleucel is the establishment of a well-controlled manufacturing process that can consistently produce high-quality CAR T cells that are safe, pure, and potent.”

The new treatment uses a technology known as CAR T-cell immunotherapy. CAR T-cell therapy works by genetically modifying the patient’s own T cells so that they can recognize and kill cancer cells without damaging normal cells. That’s why some scientists refer to this treatment as a “living drug.”

“CAR T-cells are a promising therapy, but the current state of biomanufacturing is very complex, expensive and time-consuming, often requiring multiple rooms, highly skilled technicians and many instruments,” said Tara S. Clark, vice president of commercial programs at Draper. “What’s needed is a bioprocessing platform that can help cell therapy developers bring their therapies to market more quickly, safely and affordably.”

Draper has addressed this challenge by working to develop microfluidic platforms that will perform key steps of the CAR T-cell manufacturing process, as well as processes for other types of cell therapies. Draper’s innovations include a technique known as acoustophoresis for separating and enriching the immune system cell population that includes T cells using sound energy, as well as a platform for accelerating the process for transferring genetic material into T cells from the current one-to-three days to less than a day.

The goal of Draper’s microfluidic technologies is to create improvements in the cell therapy manufacturing process by combining fluidic control, precision and the ability to scale to higher throughput systems for easy integration with existing manufacturing equipment. The anticipated result will be a lower-cost, high-quality therapy that can be produced more quickly than is possible with current methods.

“Companies are trying to break through the bioprocessing bottleneck so they can scale up without losing quality,” said David O'Dowd, associate director of biomedical solutions at Draper. “As the cell therapy community moves closer to achieving the goal of a closed, end-to-end system that automates cell therapy bioprocessing—and delivers downstream benefits such as standardizing processes and minimizing human error and the risk of contamination—Draper will continue to deliver solutions that matter.”

Draper’s microfluidic platform can accelerate the process for transferring genetic material into T cells from the current one-to-three days to less than a day. Shown here is the disposable component of the system’s transduction device.
Capabilities Used

Draper has designed and developed microelectronic components and systems going back to the mid-1980s. Our integrated, ultra-high density (iUHD) modules of heterogeneous components feature system functionality in the smallest form factor possible through integration of commercial-off-the-shelf (COTS) technology with Draper-developed custom packaging and interconnect technology. Draper continues to pioneer custom Microelectromechanical Systems (MEMS), Application-Specific Integrated Circuits (ASICs) and custom radio frequency components for both commercial (microfluidic platforms organ assist, drug development, etc.) and government (miniaturized data collection, new sensors, Micro-sats, etc.) applications.  Draper features a complete in-house iUHD and MEMS fabrication capability and has existing relationships with many other MEMS and microelectronics fabrication facilities. 

Biomedical Solutions

Draper’s Biomedical Solutions capability centers on the application of microsystems, miniaturized electronics, computational modeling, algorithm development and image and data analytics applied to a range of challenges in healthcare and related fields. Draper fills that critical engineering niche that is required to take research or critical requirements and prototype or manufacture realizable solutions.  Some specific examples are MEMS, microfluidics and nanostructuring applied to the development of wearable and implantable medical devices, organ-assist devices and drug-delivery systems. Novel neural interfaces for prosthetics and for treatment of neurological conditions are being realized through a combination of integrated miniaturized electronics and microfabrication technologies.

Materials Engineering & Microfabrication

Draper continues to develop its expertise in designing, characterizing and processing materials at the macro-, micro- and nanoscales. Understanding the physical properties and behaviors of materials at these various scales is vital to exploit them successfully in designing components or systems. This enables the development and integration of biomaterials, 3D printing and additive manufacturing, wafer fabrication, chemical and electrochemical materials and structural materials for application to system-level solutions required of government and commercial sponsors.

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