ChromaTan, a bioprocessing and biotools technology platform development company based in Lower Gwynedd, PA, has been awarded a $2 million Phase IIB NIH grant by the National Institute of General Medical Sciences. The funding will be utilized to further develop and integrate ChromaTan’s innovative BioRMB™ technology for manufacturing adeno-associated viruses (AAVs).
Fund Utilization
The NIH grant will be directed towards:
- Development of BioRMB™ Technology: Advancing ChromaTan’s single-use, column-free, steady-state continuous counter-current elution technology.
- AAV Purification: Creating process trains for the purification of at least two AAV serotypes, sourced from ChromaTan’s commercial partners. This includes both capture and polishing steps, such as empty/full separation.
- Scaling Production: Scaling the BioRMB™ platform to pilot and large-scale current good manufacturing practice (cGMP) production levels.
Company Overview
ChromaTan, founded to revolutionize biomanufacturing, has developed the BioRMB™ system, previously known as Continuous Countercurrent Tangential Chromatography (CCTC). Launched in 2023, the BioRMB™ platform offers significant improvements in productivity, product recovery, and product quality for various biologics, including gene therapies, mRNA, and monoclonal antibodies.
Key Features and Benefits of BioRMB™
- Column-Free Technology: Eliminates the need for traditional chromatography columns, reducing costs and complexity.
- Steady-State Continuous Processing: Enhances efficiency by maintaining a steady state, leading to higher productivity.
- Improved Purification: Offers superior purification processes, particularly for complex biologics such as AAVs, mRNA, and monoclonal antibodies.
- Single-Use System: Designed to be single-use, minimizing contamination risks and simplifying the workflow.
Project Goals
- Enhanced AAV Purification: Developing robust purification processes for AAV serotypes to ensure high purity and quality.
- Scale-Up for cGMP Production: Transitioning the BioRMB™ platform from pilot to large-scale production, adhering to cGMP standards.
- Collaboration with Commercial Partners: Working with partners to tailor the purification processes to specific AAV serotypes.
Strategic Importance
The NIH grant supports ChromaTan’s mission to innovate biomanufacturing processes, particularly for gene therapies. The BioRMB™ platform’s enhancements in productivity and quality can significantly impact the production efficiency and scalability of AAVs, which are critical for gene therapy development and commercialization.
Future Outlook
With the NIH funding, ChromaTan is positioned to make substantial advancements in AAV manufacturing, potentially setting new standards in bioprocessing technology. The continued development and scaling of the BioRMB™ platform promise to enhance the efficiency and quality of biologics production, benefiting both the biopharmaceutical industry and patients relying on advanced therapies.
