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

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.