# Resubmission - Development and scale-up of Continuous Countercurrent Tangential Chromatography (CCTC) for next generation AAV vector manufacturing (Direct to Phase II)

> **NIH NIH R44** · CHROMATAN CORPORATION · 2024 · $1,304,417

## Abstract

PROJECT SUMMARY
The overall goal of the proposed Direct to Phase II SBIR project is to commercialize Continuous
Countercurrent Tangential Chromatography (CCTC) for recombinant AAV purification. This
novel platform will enable column-free, continuous, and single-use purification of rAAVs.
Successful commercialization of the CCTC system in this field will lead to at least a 50% reduction
in downstream production costs, increased recoveries (by 40%) and improved product quality for
these life saving therapies that provide effective treatments and cures for such conditions as
cancer, hemophilia and many others.
Continuous and flexible single-use processing for biologics has been established as a significant
unmet need. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research,
stated in a 2011 AAPS meeting: “It is predicted that manufacturing will change in the next 25
years as current manufacturing practices are abandoned in favor of cleaner, flexible, more
efficient continuous manufacturing.” Significant bottlenecks in downstream processing as well
as the explosive growth in the number of gene therapies and specifically rAAVs in development
are the primary drivers of this unmet need.
Our aim is to commercialize CCTC for the purification of rAAV to significantly improve
recovery, product quality, and process productivity when compared with status-quo column
chromatography. CCTC provides a steady state purification platform with >10x reduction in
cycle time and greater productivity compared to current column-based purification. Preliminary
data obtained with a commercial rAAV product show at least a 5-15x increase in productivity
and 15-20% improvement in recovery for a capture operation. In addition, because the
CCTC platform runs at low pressure, small particle size resins may be used to significantly
increase binding capacity and resolution. This feature could enable finely tuned and gradient-
free operation for the separation of empty vs. full capsids. The promise of this system was
recognized by 2 market leading rAAV companies – Batavia and Spark – both of which will
support this work by providing hundreds of liters of material, access to their facilities and
analytical support. Additional collaborations with MIT and BTEC will assist with process
modeling, integration and scale up evaluations.
The proposed work will enable:
1) Development of a comprehensive process development toolkit for benchtop
 experimental design, modeling and analytics required to execute CCTC capture and
 polishing operations for rAAV purification
2) Generation of pilot scale process CCTC data with at least 3 rAAV serotypes including
 at least 2 AAVs from commercial partners Spark and Batavia
3) Integration of CCTC capture and polishing operations for at least 2 rAAV at pilot scale
4) Demonstrated scale up operations in cGMP environment at 50 – 200 L scale
5) Economic modeling via Biosolve platform to enable objective comparison to status-quo
 platfo...

## Key facts

- **NIH application ID:** 10921694
- **Project number:** 1R44GM154572-01A1
- **Recipient organization:** CHROMATAN CORPORATION
- **Principal Investigator:** Oleg Shinkazh
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,304,417
- **Award type:** 1
- **Project period:** 2024-05-15 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10921694

## Citation

> US National Institutes of Health, RePORTER application 10921694, Resubmission - Development and scale-up of Continuous Countercurrent Tangential Chromatography (CCTC) for next generation AAV vector manufacturing (Direct to Phase II) (1R44GM154572-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10921694. Licensed CC0.

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