image credit- shutterstock
US-based AGC Biologics, a global Contract Development and Manufacturing Organisation (CDMO), has announced a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea.
Novelty Nobility will leverage AGC Biologics’ expertise and proprietary CHEF1 expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics’ Copenhagen, Denmark and Chiba, Japan facilities.
Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively.
AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility’s first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March.
AGC Biologics' CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialisation.