Performance Period: 8/15/2018 to 2/28/2021
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. NC State University, ILC Dover, and Genentech will work together to evaluate diamond-like carbon coatings in a GLP laboratory environment using industry-relevant samples and standards (i.e., MRL 4 project activities).
An overall approach described by U.S. Pharmacopeia that involves material screening, controlled extraction (simulation), and product assessment steps will be utilized. In the materials screening steps, surface resistivity studies, mechanical assessment studies, oxygen transmission studies, protein adsorption studies, and in vitro biological studies will be performed. The controlled extraction (simulation) study will simulate the release of leachables from the diamond-like carbon coated vessels under worst case parameters. The product assessment step will involve the measurement of leachables in a biopharmaceutical therapeutic product under commercial biopharmaceutical manufacturing conditions.
If the proposed project is successful, then the biopharmaceutical industry will have an optimized approach for applying diamond-like carbon coatings to vessels that are used in biopharmaceutical manufacturing. A report describing the performance of the diamond-like carbon coated vessel will be prepared, which will facilitate implementation of diamond-like carbon coating technology in biopharmaceutical manufacturing.
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North Carolina State University