Use of Carbon Thin Films to Reduce Leachable Contamination

The proposal seeks to minimize the release of leachables from single-use vessels used in biopharmaceutical manufacturing by depositing hydrogenated diamond like carbon coatings on the interior surfaces of these vessels.
Categories
Equipment and Supplies

Industry Need

Disposable single-use components are essential for biopharmaceutical manufacturing, unfortunately are commonly affected by contamination from extractables and leachables that adversely affect efficacy and quality.

Approach

The implementation of a diamond-like carbon coating could minimizes or eliminates the formation of leachables in single-use components.

Impacts

Develop a standardized approach for depositing diamond like carbon coating on single use vessels to minimize the release of leachables

Minimize the need for extensive functional tests typically required for disposable vessels

Value Statement/Outcomes

By implementing diamond-like carbon (DLC) coating technology on single-use biopharmaceutical components, an organization could reduce contamination risks from leachables and extractables—key cost drivers for product quality failures and regulatory delays, enabling faster commercialization and improved patient safety.

Outputs/Deliverables

Understand the adhesive and mechanical properties of the DLC coating on ILC Dover 5L vessels as well as demonstrate that the 5L vessels are more biocompatible for cell growth vs uncoated vessels

Understand the complete set of physicochemical properties of DLC coated ILC Dover materials as well as obtain processing parameters that optimize the DLC coated materials in terms of biocompatibility and mechanical performance under worst case scenarios

Publications

Movahed, S., Nguyen, A. K., Goering, P. L., Skoog, S. A., & Narayan, R. J. (2020). Argon and oxygen plasma treatment increases hydrophilicity and reduces adhesion of silicon-incorporated diamond-like coatings. Biointerphases, 15(4). https://doi.org/10.1116/6.0000356

Riley, P. R., Yang, K., Liu, Y., Skoog, S. A., Narayan, J., & Narayan, R. J. (2023). Effect of oxygen and fluorine plasma surface treatment of silicon-incorporated diamond-like carbon coatings on cellular responses of mouse fibroblasts. International Journal of Applied Ceramic Technology, 20(2), 879-883. https://doi.org/10.1111/ijac.14107

Riley, P., Joshi, P., Azizi Machekposhti, S., Sachan, R., Narayan, J., & Narayan, R. (2021). Enhanced Vapor Transmission Barrier Properties via Silicon-Incorporated Diamond-Like Carbon Coating. Polymers, 13. https://doi.org/10.3390/polym13203543

Presentations

Movahed, S., Nguyen, A., Goering, P., Skoog, S., & Narayan, R., Characterization of plasma enhanced chemical vapor deposition diamond-like carbon coatings on fused silica with and without argon or oxygen plasma treatment, Chemical Society 2020 Fall Meeting, San Francisco, CA, August 16, 2020.

Narayan, R. J., Use of Carbon Thin Films to Reduce Leachable Contamination, Carolina Science Symposium, Virtual, November 12, 2020.

Narayan, R., Plasma-enhanced chemical vapor deposition of silicon-containing diamond-like carbon thin films, 44th International Conference & Exposition on Advanced Ceramics & Composites, Daytona Beach, FL, January 28, 2020.

Narayan, R., Use of Carbon Thin Films to Reduce Leachable Contamination, 2019 NIIMBL National Meeting, Washington, DC, June 28, 2019.

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Project Lead

North Carolina State University

North Carolina State University

Participating Organizations

Genentech, Inc.

Genentech, Inc.

ILC Dover LP

ILC Dover LP