HJB & Ansun Enter Into Strategic Agreement For CMC Development
China-based HJB, a biologics Contract Development and Manufacturing Organization (CDMO) committed to quality, reliability and speed for each and every CMC (chemistry, manufacturing and control) package delivered to its partners announced that it has entered into a strategic partnership for CMC development and manufacturing with Ansun Biopharma (Ansun), a clinical-stage biopharmaceutical company based in California, on its therapeutic biologics pipeline. The first program is expecting to submit an Investigational New Drug (IND) application in 2021.
Under the agreement, Ansun will have the ability to leverage HJB's comprehensive expertise and capacities from cell line development, process and assay development to GMP manufacturing, IND-enabling full-service package and clinical and commercial supply in the global territory for the next three years. The agreement provides strong support for Ansun's development goals and potential significant acceleration of its portfolio to market.
HJB has taken more than 20 CDMO projects, delivered 30 batches of GMP products, and has been recognized by its global partners for quality, reliability and speed. Currently, HJB's comprehensive capabilities include cell line and cell bank development, process and formulation development, technology transfer and optimization as well as GMP manufacturing, with three DS production lines (500 – 2,000L), and a DP fill-and-finish line. HJB has served more than double the amount of client programs during the first half of 2020 despite a minimal disruption of operation due to COVID-19. The performance demonstrated HJB's commitment to execution, delivery, and quality system