Aug, 2018
Dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners, HJB today announced the completion of the first batch of GMP clinical samples, which meet GMP requirements on drug substance, personnel, facility, manufacturing process and quality control.
HJB’s Co-founder and President Dr. Jonathan Zhao said, “The first successful batch of clinical samples marked HJB’s complete and globally leading manufacturing capability and quality system. With world-leading R&D strengths and next-generation manufacturing platform, HJB has been working with multiple overseas partners to make changes by pushing forward the development and manufacturing of biologics in the world.”
HJB’s R&D Center and Manufacturing Facility was completed in early 2018 and has been operational ever since. It is not only equipped with leading next-generation flexible manufacturing modules to provide highly intensive biological process manufacturing but also compliant to GMP standards in China, the US and EU. Currently, the facility has seven cleanroom manufacturing modules and two 500L bioreactor product lines, ensuring flexible multi-product capability. It is expected that two 2000L product lines will be added to the facility in early 2019 to increase total annual output of 1 ton monoclonal antibodies.