# SBIR TOPIC 445- ADVANCED MANUFACTURING TO SPEED AVAILABILITY OF EMERGING AUTOLOGOUS CELL-BASED THERAPIES

> **NIH NIH N43** · ELATE MEDICAL, INC. · 2022 · $400,000

## Abstract

Current practice of T cell therapy drug manufacturing involves collection, shipment of the blood to a manufacturing site, manufacturing of the drug in a cleanroom environment by a trained technologists, analytical assays for drug release, and the final shipment of frozen product back to the treatment site. The cost and time involved in manufacturing process, analytical assays, and a regulatory approval create a huge
bottleneck to rapid translation of early phase, innovative products. Our long-term objective is to develop a device (EM01) that can implement a point of care walk-away operation to significantly simplify the cost, time, and a regulatory approval of the cell therapy manufacturing. EM01 will be designed to eliminate cryopreservation and shipping of incoming material and final product, to operate in a non-cleanroom environment by minimally trained personnel, and to integrate automated analytical assay system. Specific to this proposal, we will build a prototype integrated cell culture chamber and flow guide with in-chamber cell isolation and for in-process monitoring of glucose, oxygen, cell density, transgene expression, and microbial assays. Cell products manufactured from the prototype will then be benchmarked against the CAR T products manufactured following a clinical protocol using CliniMACS Prodigy system.

## Key facts

- **NIH application ID:** 10701477
- **Project number:** 75N91022C00026-0-9999-1
- **Recipient organization:** ELATE MEDICAL, INC.
- **Principal Investigator:** MARK STASIAK
- **Activity code:** N43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $400,000
- **Award type:** —
- **Project period:** 2022-09-15 → 2023-09-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10701477

## Citation

> US National Institutes of Health, RePORTER application 10701477, SBIR TOPIC 445- ADVANCED MANUFACTURING TO SPEED AVAILABILITY OF EMERGING AUTOLOGOUS CELL-BASED THERAPIES (75N91022C00026-0-9999-1). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10701477. Licensed CC0.

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