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
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 and Elpiscience signed a strategic partnership agreement according to which HJB will offer one-stop services that not only cover from cell line, process, formulation development to clinical manufacturing, but also meet IND requirements in both China and the US, to Elpiscience’s innovative monoclonal antibody drug for the treatment of tumors.
“HJB is dedicated to providing high quality, reliable and efficient biologics R&D and manufacturing services to partners across the world,” HJB’s General Manager of CDMO Dr. Jerry Yang added, “We are truly excited to work with an innovative company such as Elpiscience. We are going to help them gain a leg up on the fierce competition of innovative antibody-based drugs and create more values for our partners.”
At HJB, we have put in place a world-leading biologics development and manufacturing platform as well as an experienced team. In the past year we have provided high quality and efficient development and manufacturing services to over ten clients working on innovative medicines with some GMP samples already used in clinical trials. In the partnership, HJB will leverage its capabilities and experience to help Elpiscience meet or even push ahead the timeline for development and clinical trial.
Recently, HJB delivered monoclonal antibodies to Taizhou Houde Aoke Technology, a subsidiary of Lepu Biotech Co., Ltd. ("Lepu Biotech"), and these antibodies have entered clinical trials and were successfully administered to patients. It is the first product manufactured by HJB under GMP conditions to enter clinical trials since the company started operation in January 2018, which marks an important milestone for HJB’s GMP manufacturing capability and CDMO services.
This project started in mid-April 2018. HJB delivered the first batch of GMP products to the client in one-time manner in October, and the first patient dosing has been conducted in the clinical trials in early December. It is HJB’s high standards of GMP quality management system, manufacturing , operation and service mindset that ensured excellent drug quality and efficient production.
To be able to complete GMP production and dosing of patients in such a short time, Lepu Biotech’s technical team commented: "Currently we are facing extremely fierce competition, but HJB has provided great push to our drug development not only by ensuring product quality and quantity, but also completing the project ahead of schedule. HJB also offered professional and valuable insights for our IND application in China and the US. "
HJB’s Founder and President Dr. Jonathan Zhao said, “Congratulations to Lepu Biotech for on the important milestone. In this project, our team completed the technology transfer in a short time utilizing the company’s outstanding integrated platform of process and manufacturing. This will be the beginning for us to create more values for our partners in the future."
Since completed and operational in January this year, HJB has passed on-site equipment and facilities verification, established quality management system and completed the GMP production and release for the first IND project. HJB is dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners.
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.
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.
Dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners, HJB announced today the completion of a $35 million Series B+ financing round.
Hillhouse Capital (Hillhouse), a Beijing and Hong Kong-based investment firm, leads this financing, with participation by existing investors Temasek, Lilly Asia Ventures (LAV), ARCH Venture Partners, Taikang and BOCGI Zheshang Capital. Including this round, HJB has raised over $120 million in financing so far.
Since last year HJB has focused predominantly in 3 areas: the completion of the R&D Center and Manufacturing Facility located in Hangzhou, establishing its R&D and clinical development capabilities and building a world-class team by attracting top talents around the world.
HJB was originally founded in 2016 by former Amgen and Genentech executives in Hangzhou, China. With the state-of-the-art biomanufacturing and process development platform, HJB can develop and manufacture antibody and recombinant proteins at a reduced cost and accelerated speed while maintaining global quality standards. HJB also employs an experienced team of scientists and engineers in its sites in Hangzhou and Boston, and is led by seasoned executives from MNCs.
HJB, an organization dedicated to expanding global access to important protein therapeutics, today held the grand opening ceremony for its R&D Center and Manufacturing Facility. Around 200 guests including business partners, investors and representatives from pharmaceutical companies were present to witness this historical moment.
Jonathan Y. Zhao, Founder and CEO of HJB, delivered a speech at the opening ceremony. He reviewed the progress HJB has made since its establishment, and stressed that “HJB has reached another important milestone. This is a great step towards our mission of expanding global access to biotherapeutics. We will further leverage the 3rd-generation biologics platform to develop and manufacture high quality biologics for patients around the world.”
Over the past two years, HJB has secured a total of USD 67 million in financing from Lilly Asia Ventures, ARCH Venture Partners, Temasek, Taikang, HEDA and other investors, and has grown rapidly. HJB completed the 140,000 sq.ft R&D Center and GMP Manufacturing Facility which will supply the global market with clinical and commercial product.
HJB and G-CON Manufacturing, Inc. today announced that the companies are working together on HJB’s state-of-the-art biologics facility in the Hangzhou Economic & Technology Development Area (HEDA) in China. The cGMP facility is expected to be completed and operational in early 2018.
This will be the first commercial facility for HJB. With cutting-edge technologies and the flexible and rapidly deployable PODs, HJB will be able to reduce time for development and manufacturing cost, while at the same time creates a new standard for bioprocessing industry facilities.
HJB was founded in 2014, dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners. In this application PODs will be referred to as T-BLOC, representing the fully equipped processing units capable of running highly intensified bioprocesses.
Maik Jornitz, CEO and President of G-CON Manufacturing, stated, “Our flexible, compact PODular cleanroom systems are becoming an attractive and cost-efficient alternative for the industry, compared to traditional brick and mortar or stick built systems. We very much appreciate the teamwork together pursuing our facility innovation for HJB’s inaugural commercial scale facility. And we look very much forward to continuing the team work to help change the drug manufacturing paradigm.”
HJB’s facility will be in the Hangzhou Economic & Technology Development Area, an area founded in 1993 as one of China's first state level development zones. The HEDA is a international industrial, scientific and manufacturing zone producing a number of high value products including biologic drugs, microelectronics, mobile telecommunications, optical equipment products, automobile products, chemicals and computers.