Raman spectroscopy quality controls for GMP compliant manufacturing of tissue engineered cartilage

Laura Power; Anke Wixmerten; David Wendt; Andrea Barbero; Ivan Martin

doi:10.1117/12.2507951

4 March 2019 Raman spectroscopy quality controls for GMP compliant manufacturing of tissue engineered cartilage

Laura Power, Anke Wixmerten, David Wendt, Andrea Barbero, Ivan Martin

Proceedings Volume 10881, Imaging, Manipulation, and Analysis of Biomolecules, Cells, and Tissues XVII; 108810F (2019) https://doi.org/10.1117/12.2507951
Event: SPIE BiOS, 2019, San Francisco, California, United States

Abstract

We are engineering cartilage from autologous nasal chondrocytes and a collagen scaffold in chondrogenic conditions to treat knee cartilage defects in an ongoing phase II clinical trial. To comply with regulatory requirements, we are developing quality controls to characterize and ensure the safety and quality of the engineered cartilage products. Our preliminary results show that we can measure the Raman spectra of engineered cartilage. Here we propose a standardized procedure for collecting and preprocessing the Raman spectral data. We currently have experienced, trained technicians manufacturing the engineered cartilage, but in the future, these grafts will be made by various labs, therefore ensuring the standardization of the manufacturing process is a challenge that could be addressed with Raman spectroscopy-based quality controls. In this manuscript we discuss how Raman spectroscopy-based quality controls could be incorporated into the Good Manufacturing Practice (GMP) compliant process for our engineered cartilage.

Conference Presentation

Citation Download Citation

Laura Power, Anke Wixmerten, David Wendt, Andrea Barbero, and Ivan Martin "Raman spectroscopy quality controls for GMP compliant manufacturing of tissue engineered cartilage", Proc. SPIE 10881, Imaging, Manipulation, and Analysis of Biomolecules, Cells, and Tissues XVII, 108810F (4 March 2019); https://doi.org/10.1117/12.2507951

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