Robust and Scalable GMP Manufacturing of Chondrocyte Cell Therapy for Cartilage Regeneration

By Vinayak Virupaksh Kedage, Rajesh Pratap Singh, Parvathi Chandran, Vidya Jadhav, Sujata Shinde, and Satyen Sanghavi
Volume 20, Open Access (Nov 2021)

Cell therapy has emerged as a promising technology that involves implanting live cells to replace/repair and restore normal function of damaged tissue. Autologous chondrocyte implantation (ACI) has been proven effective for the regeneration of articular cartilage in defective cartilage tissue. The process starts with the collection of healthy tissue from an eligible patient, then isolation and expansion of desired cells in vitro under good manufacturing practice (GMP) conditions, qualification before release of the final cell product, and finally, implantation into the patient. The promise to deliver autologous cell therapies has its own challenges in robust and reproducible manufacturing. To commercialize a cell therapy, it is imperative that a robust and scalable manufacturing process is set up that is consistent, in terms of quality and quantity, in order to deliver the intended therapeutic effect.

We analysed the manufacturing parameters of over 100 cartilage samples that were used to deliver our proprietary, commercialized autologous cell therapy. The paper addresses the most cited challenges in the manufacturing of autologous cell therapies and describes a robust process of in vitro human chondrocyte cell culture. Also included are key factors in manufacturing for attaining a high-quantity and quality product for articular cartilage regeneration.

Kedage VV, Singh RP, Chandran P, Jadhav V, Shinde S, Sanghavi S. Robust and scalable GMP manufacturing of chondrocyte cell therapy for cartilage regeneration. BioProcess J, 2021; 20.

Posted online November 1, 2021.