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Consortium Aims to Upgrade Cell Manufacturing

Microfluidic cell device

Microfluidic device to capture cancer cell clusters in blood samples (Rob Felt, Georgia Tech)

13 June 2016. A collaboration between businesses and universities outlined a strategy to develop processes and technologies for large-scale manufacturing of human cells for therapies and diagnostics. The National Cell Manufacturing Consortium, residing at Georgia Institute of Technology, announced its technology road map for advance cell manufacturing today at a White House conference on organ transplants.

The consortium seeks to create faster as well as more reliable and consistent techniques for generating human cells used in treatments and tissue engineering, as well as medical devices, drug discovery platforms, and organ-on-chip models that test drugs for toxicity. The consortium says several federal agencies spent as much as $3 billion on research in regenerative medicine that yielded promising cell-based technologies, but the ability to produce human cells in sufficient quantities and in consistent high quality, needed for day-to-day use of those technologies, is lagging behind.

The road map, originally published in February 2016, offers a strategy through 2025 for participants in the cell manufacturing community — pharmaceutical and biotech companies, medical device developers, academic institutions, private foundations, and federal agencies — to produce this capability at a large scale and high, consistent quality. The strategy covers manufacturing of autologous cells provided by patients for retransplant, donated or allogenic cells, and pluripotent stem cells that transform or differentiate from an immature state to working cells in the body.

Achieving this goal, says the consortium, requires the cell manufacturing community to work along two tracks. The first track upgrades current technologies for cell processing, preservation and distribution, and quality assurance. Cell processing technologies cover screening and selection methods, culture media, cell expansion methods and equipment, separation techniques, and cell modification and differentiation methods.

Cell preservation and distribution includes cryopreservation techniques, storage technologies, and systems for tracking the movement of cell products. Processes for monitoring and quality assurance cover cell attribute testing and measurement, as well as data analytics and management.

A second simultaneous track aims to strengthen the industry’s business infrastructure. One part of this track aims to upgrade the industry’s workforce through training, higher education, and more cross-industry collaboration. Another part of strengthening the foundation aims to enhance standardization and regulation, through development of quality standards, more consistency in the supply chain, and improved regulatory strategies.

The road map calls for additional investments in advanced cellular manufacturing to maintain U.S. leadership in the field, noting similar national initiatives in the U.K., Canada, Australia, and Germany. While the document did not spell out specific numbers, the consortium estimates the need for “several hundred million dollars a year” for the next 10 years. The report says its members are prepared to provide monetary and in-kind support, but “additional or matched external or federal funding would multiply the impact of the consortium’s efforts.”

National Cell Manufacturing Consortium was established in 2014, and now has some 60 representatives from industry, government, and not-for-profit organizations. The group is funded by an advanced manufacturing technology grant from National Institute of Standards and Technology.

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