en.Wedoany.com Reported - US cell therapy contract development and manufacturing organization (CDMO) Made Scientific has been selected as the manufacturer of NOVAKnee, a biological total knee replacement developed by researchers at Columbia University’s School of Engineering and Vagelos College of Physicians and Surgeons in New York, USA.

The project is part of the Advanced Research Projects Agency for Health (ARPA-H) NITRO (Novel Innovations for Tissue Regeneration in Osteoarthritis) program, led by Dr. Ross Uhrich. Made Scientific will be responsible for technology transfer, analytical and process development, as well as clinical production under Good Manufacturing Practice (GMP) conditions for NOVAKnee-T and NOVAKnee-L implant drug substance and drug product. These implants are intended for a US Phase I study expected to begin in 2028.

NOVAKnee aims to provide an alternative to traditional knee replacement through a living biological approach. The implant utilizes a biodegradable scaffold loaded with bone and cartilage progenitor cells. Its goal is to restore joint function through biological tissue regeneration, rather than relying on traditional mechanical components such as metal or plastic.

Syed Husain, Chairman and CEO of Made Scientific, stated that the project reflects a significant shift in orthopedic care by replacing traditional implants with living cell products. The company is committed to providing superior manufacturing capabilities to bring NOVAKnee from the lab to patients. ARPA-H’s NITRO program supports Columbia University’s NOVAJoint project, which focuses on advancing next-generation biological solutions for joint replacement.

Made Scientific’s involvement in this project highlights the company’s continued engagement in cell therapy manufacturing for clinical programs stemming from academic research. This US-based CDMO specializes in the production and release of autologous and allogeneic products for clinical and commercial use, supported by GC Corporation, which operates globally in the pharmaceutical and biotechnology sectors.

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