# Continuation Application for the development of Integrated continuous and single-use (ICS) bioproduction platform (Phase IIB)

> **NIH NIH R44** · CHROMATAN CORPORATION · 2022 · $1,284,233

## Abstract

PROJECT SUMMARY / ABSTRACT
The overall goal of the proposed Phase IIB SBIR project is to commercialize an Integrated
Continuous and Single-use bio-production platform (ICS) for flexible and robust
manufacturing of therapeutic proteins. This novel platform will enable continuous, single-use, and
low cost purification of therapeutic proteins. Successful commercialization of the ICS system will
lead to at least a 50% reduction in production costs for life saving therapies that treat conditions
such as cancer, Crohn’s disease, and Rheumatoid Arthritis.
Continuous and flexible single-use processing for monoclonal antibodies and other bio-
therapeutics 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 therapeutics in development are the primary drivers of this unmet need.
The purpose of the ICS system will be to integrate two of the most promising flexible and
continuous technologies in the market – single-use perfusion and the novel single-use
purification system called Continuous Countercurrent Tangential Chromatography (CCTC).
CCTC has shown over 10X improvement in productivity vs. conventional columns with
equivalent product quality in multiple pilot studies.
Through our Phase II efforts the CCTC pilot system is now launched to the market with the first
sale booked in 2021. We were also able to develop a 2nd generation flow path that will utilize 3D
printed Dean Vortex Separators as well as specially developed large pore size membranes
enabling long-term and fouling free operation of the ICS system.
The Phase IIB effort will focus on finalizing the pilot scale integration of the ICS framework and
scale up of the platform to cGMP. The program will be supported by multiple strategic partners –
Proconex for automation, Purolite for resin manufacturing, and NewAge Industries for single-use
and 3D printing. The project will also be supported by large biopharma players that have already
invested into our technology – Merck, Roche and Takeda.
Overall, commercialization of the ICS system will have the following impacts on bio-production:
 1. Continuous operation will lead to lower capital cost and lower equipment footprint.
 2. Single-use and closed system features will reduce capital cost, enable flexible
 manufacturing, and eliminate cleaning and cleaning validation requirements.
 3. True steady state operation will enable in-line process monitoring of bioreactor and
 purification performance, leading to better robustness and product quality.
 4. ICS flexibility will enable manufacturers to launch processes faster and at a lower cost
 resulting in better availa...

## Key facts

- **NIH application ID:** 10384023
- **Project number:** 2R44GM117682-04
- **Recipient organization:** CHROMATAN CORPORATION
- **Principal Investigator:** Oleg Shinkazh
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,284,233
- **Award type:** 2
- **Project period:** 2016-01-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10384023

## Citation

> US National Institutes of Health, RePORTER application 10384023, Continuation Application for the development of Integrated continuous and single-use (ICS) bioproduction platform (Phase IIB) (2R44GM117682-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10384023. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*