Dr. David Wendt Profile

Dr. David Wendt

at Univ Basel

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Proceedings Article | 4 March 2019 Presentation + Paper

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, 108810F (2019) https://doi.org/10.1117/12.2507951

KEYWORDS: Tissue engineering, Cartilage, Raman spectroscopy, Manufacturing, Clinical trials

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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.

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