HJB - Your Trusted Biologics CDMO Partner

HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB

HJB - Your Trusted Biologics CDMO Partner

Cn
01

Nov, 2018

HJB Delivers First Batch of Clinical Samples

Dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners, HJB today announced that it has completed the manufacture process of the first batch of GMP clinical samples and delivered to client.

The project was launched in mid-April 2018 and it took only half a year to complete process transfer, analytical method transfer and validation and the production as well as release testing of one batch of GMP-compliant product. To be able to complete the project in such a short time, HJB’s strong and comprehensive CDMO capabilities within the manufacturing facility have everything to do with it. It is equipped with not only the next-generation flexible manufacturing modules, but also a highly experienced team.

Strong and comprehensive capabilities are the key for HJB’s reputation. Located in Hangzhou, China, HJB's R&D Center and Manufacturing Facility has obtained a Drug Production License for Therapeutic Biological Products issued by the Zhejiang Medical Products Administration, and recently passed the on-site inspection by the Office of Safety Supervision of the Hangzhou Administration for Market Regulation. In addition, the facility has also passed audits multiple times by CDMO clients and third parties.

HJB has always been committed to providing partners with comprehensive and professional services, including cell line development, upstream and downstream process development, formulation research, analytical development, technology transfer, process scale-up, clinical sample production, project management and regulatory affairs. HJB’s manufacturing facility is integrated with molecular design, process design and flexible manufacturing modules, capable of significantly reducing product development cycles and improve product quality while cutting down the cost of production. In addition, HJB will add an additional 2000L production line to further enhance CDMO capabilities.