# Efficient automated processing for gene-engineered autologous cell therapies

> **NIH NIH R43** · THERMOGENESIS CORPORATION · 2021 · $253,476

## Abstract

ABSTRACT
Gene-engineered autologous cell (GEAC) therapies for hematologic cancers and inherited disorders are earning
growing numbers of FDA approvals, but manufacturing inefficiencies (90+% scrap rates) contribute to long
workflows and high costs. Current automation efforts do not offer a solution, because the cell processing
techniques they automate – like Ficoll-based cell enrichment, magnetic cell sorting (MACS), expansion and cell
washing – are themselves inefficient (in terms of cell recoveries). This Phase 1 SBIR will validate the suitability
of significantly more efficient cell handling processes (enabled by applicant’s functionally closed X-Series cell
processing cartridge and X-BACS buoyancy-based cell isolation reagents, distributed by Corning Life Sciences)
for integration into a ‘one-pot’ GEAC manufacturing workflow lending itself to full automation in the simple,
compact, moderately priced Quintessence instrument (the subject of a follow-on Phase 2 SBIR proposal).
X-Series cartridges are proven to enrich mononuclear cells from blood with target cell recovery efficiencies of
90-100% (for T cells and hematopoietic stem cells), and to wash or volume-reduce cells with equal recovery
efficiency. Similarly, X-BACS reagents used in X-Series cartridges prove 50% more efficient than conventional
MACS at target cell isolation at very high purity. Combined, these innovations can offer at least a 6-fold
improvement in cell yield relative to conventional techniques. Target blood cells thus prepared have been shown
to be transduced with lentiviral vectors as readily as are conventionally produced target cells.
This proposal’s Specific Aims are: (1) to prototype and manufacture in small quantities an enhanced X-Series
cartridge with additional features required to support the subsequent Aim; and (2) to validate and optimize the
performance of all the steps of GEAC manufacturing (from blood to transduced, expanded and washed cells
comprising a typical therapeutic dose) in a single such cartridge (‘one-pot’ workflow), the milestone for application
for a Phase 2 SBIR to design and validate the Quintessence instrument that will fully automate that workflow.
Success in delivering low-cost, high-efficiency, fully automated GEAC manufacturing technology may
substantially improve patient experiences and outcomes by enabling the industry to (1) make these therapies
more affordable; (2) reduce GEAC’s high manufacturing failure rate (failure to produce a full clinical dose); (3)
reduce lead times from Rx to treatment; (4) produce more robust cells by minimizing ex vivo cell expansion; (5)
switch from leukapheresis to peripheral blood as the manufacturing input; and (6) decentralize manufacturing to
the point of care (hospitals).

## Key facts

- **NIH application ID:** 10323695
- **Project number:** 1R43GM144400-01
- **Recipient organization:** THERMOGENESIS CORPORATION
- **Principal Investigator:** Philip Henry Coelho
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $253,476
- **Award type:** 1
- **Project period:** 2021-09-08 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323695

## Citation

> US National Institutes of Health, RePORTER application 10323695, Efficient automated processing for gene-engineered autologous cell therapies (1R43GM144400-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10323695. Licensed CC0.

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