Made Scientific has been chosen as the manufacturer for the biologic total knee replacement, NOVAKnee, which is being developed by researchers at Columbia University’s School of Engineering and Vagelos College of Physicians and Surgeons in New York, US.
The project forms part of the Advanced Research Projects Agency for Health (ARPA-H) Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) programme, led by Dr Ross Uhrich.
Made Scientific will handle technology transfer, analytical and process development, and the good manufacturing practice (GMP) clinical manufacturing of both drug substances and drug products of the NOVAKnee-T and NOVAKnee-L implants.
The implants are intended for use in a Phase I study in the US, which is expected to commence in 2028.
NOVAKnee is designed to offer an alternative to conventional knee joint replacements by using a living biologic approach. The implant uses a biodegradable scaffold seeded with bone and cartilage progenitor cells.
Its goal is to restore joint function through the regeneration of biological tissue rather than relying on traditional mechanical components such as metal or plastic.
Made Scientific chairman and CEO Syed Husain said: “This programme reflects a bold shift in orthopaedic care by replacing a traditional implant with a living, cell-based product. We are committed to delivering the manufacturing excellence required to advance NOVAKnee from the laboratory to patients.”
The ARPA-H NITRO programme supports Columbia University’s NOVAJoint initiative, which is focused on advancing next-generation biologic solutions for joint replacement.
Made Scientific’s involvement in the project highlights the company’s ongoing participation in cell therapy manufacturing for clinical programmes emerging from academic research.
The US-based cell therapy contract development and manufacturing organisation (CDMO) specialises in the production and release of autologous and allogeneic products for both clinical and commercial use.
It is backed by GC Corporation, which operates in the global pharmaceutical and biotechnology sectors.
