HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner

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Company News

06Jul, 2021

HJB Congratulates its partner for receiving IND approval from NMPA

HJB congratulates its partner for receiving IND approval from NMPA.

05Jul, 2021

HJB Congratulates Miracogen for receiving IND acceptance for MRG004A from NMPA

HJB Congratulates its partner Miracogen for receiving IND acceptance from NMPA for MRG004A, an tissue factor-targeted antibody–drug conjugate. 

01Jun, 2021

HJB's Automated Drug Product Vial Filling Line Is Ready for Clinical Projects

HJB has installed, commissioned, and validated a new Bosch fully isolated and automated drug product vial filling line and is ready for clinical projects. 

13Apr, 2021

HJB Congratulates its partner for receiving IND approval from U.S.FDA

HJB congratulates its partner for receiving IND approval from FDA.

08Sep, 2020

HJB Announced Successful Bi-specific Antibody Perfusion GMP Process at 200L Scale

HJB, a biologics CDMO located in Hangzhou, announced a successful GMP bi-specific antibody perfusion process at 200L scale for a client.


"This is an important milestone at HJB as we develop and implement highly productive perfusion platform using in-house developed chemically defined media," said Dr. Chris Hwang, Head of Platform Technology of HJB. "Given the high volumetric productivity of our perfusion processes, typical pre-pivotal clinical demand can be met with<200L scale single use bioreactor (SUB) while commercial supply can be met with 500L scale SUB."  


This is another key milestone for HJB's perfusion platform after achieving productivity to greater than 4 g/L per day for multiple cell lines earlier this year. With continuous technological innovations, HJB is committed to providing high quality, very reliable and fast CDMO service for each and every CMC package delivered to its biologics' partners.


27Aug, 2020

HJB and Ansun Biopharma Enter Strategic Agreement on Biologics CMC Development and Manufacturing Partnership

HJB, a biologics Contract Development and Manufacturing Organization (CDMO) committed to quality, reliability and speed for each and every CMC package delivered to its partners, announced it entered into a strategic partnership for CMC development and manufacturing with Ansun Biopharma, a clinical stage biopharmaceutical company, 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 a strong support for Ansun’s development goals and a potential significant acceleration of its portfolio to market.

“We are very excited about this strategic agreement with HJB, which we consider to be a key piece of foundation for advancing Ansun’s strong biologics pipeline in the coming years,” said, George Wang, Sc.D, Chief Technology Officer of Ansun. “As the company continues to expand its pipeline by advancing more early stage assets into clinical development, a partnership with a reliable and capable CDMO such as HJB will accelerate the successful transition of the promising sciences into clinical benefit for global patients.”

“We are proud to be selected as the CMC development and manufacturing partner of Ansun to support expedited and high-quality packages of their innovative biologics programs,” said Jerry Yang, Ph.D., General Manager of HJB. “A robust and top-notch supply chain is fundamental to biotech to achieve speed and success to market. The recent global disruption on drug development and manufacturing capacities due to a pandemic has made it even more pressing for companies to secure the much needed capacities while remaining focused and agile. We will continue creating value as a dedicated CDMO by empowering all our global and domestic partners to bring better treatments to the patients.”

Since its Hangzhou facility's first GMP run in mid-2018, 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 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.
 
About Ansun Biopharma
Ansun Biopharma is a clinical stage biopharmaceutical company based in San Diego, California, developing first-in-class biologic therapeutics to treat the unmet medical needs of vulnerable patient populations.  For more information on Ansun Biopharma, please visit the company's website at www.ansunbiopharma.com.

08May, 2020

HJB and Mabspace Biosciences' Development and Manufacturing Agreement for Novel Humanized Claudin18.2 Monoclonal Antibody Accomplished FDA and NMPA IND Clearance

HJB, a biologics CDMO committed to quality, reliability and speed for each and every CMC package delivered to its partners, today announces that its partner Mabspace Biosciences has received Investigational New Drug (IND) clearance from both the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA), for a humanized Claudin18.2 monoclonal antibody program.


Per the development and manufacturing agreement between HJB and Mabspace Bioscience, HJB provided one-stop shop end-to-end CMC package for the Claudin18.2 antibody, from DNA synthesis, process development, DS and DP GMP manufacturing to CMC dossier preparation for IND.  


"We are thrilled to have achieved dual-filing in such a short time. This is truly a great milestone for us," said Dr. Xueming Qian, Founder and Chief Executive Officer of MabSpace Biosciences. "HJB's one-of-a-kind platform not only allowed us a speedy IND submission and clearance, but also added more values to our program. We are very excited to have the opportunity to test this differentiated Claudin18.2 antibody in cancer patients and bring more efficacious treatment options to cancer patients around the world."


"Congratulations to Mabspace Bioscience for the dual-IND clearance. We are proud to be the CMC and manufacturing partner to enable this accelerated and high-quality development package," said Dr. Jerry Yang, General Manager of CDMO Business of HJB. "It is fundamental to our CDMO business to create values for our partners. In this case, our efficient and innovative development and manufacturing platform successfully shortened the total program time and further increased the molecule's biological activity independent of molecule engineering which is typically how other companies approach the challenge and often leads to freedom-to-operate limitations later on."


HJB's platform approach was proven highly adaptable and robust during this program. After receiving DNA sequence in September 2018, HJB significantly increased this antibody's ADCC activity through process optimization, delivered GLP toxicology study material in 9 months and completed all CMC work required for FDA and NMPA filing in 14 months. The result dramatically accelerated the overall timeline and allowed the program to reach first-in-human milestone with high quality Phase I clinical material ahead of other competitors.


Since its facility's first GMP run in mid-2018, HJB has taken on over 20 CDMO projects, delivered 15 batches of GMP products and 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 - 2000L) and a DP fill-and-finish line.


02Apr, 2020

HJB and 908 Devices Expand Joint Innovation Partnership

Dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners, HJB today announced an expansion of their joint innovation partnership with 908 Devices, a pioneer of analytical devices for chemical and biomolecular analysis.

Back in mid-2018, HJB entered into a partnership to bring in 908 Devices' ZipChip system that has been a critical part of the analytical toolset - streamlining internal processes and enabling rapid measurement of Critical Quality Attributes (CQAs), native proteins, and small molecules. HJB will now deploy 908 Devices' Rebel system, a first of its kind analyzer for at-line analysis on key components in cell culture media, to accelerate our process development cycles.

"We value our partnership with 908 Devices and their ZipChip has become our workhorse for large molecule and media component analyses.  When integrated with our mass spec, it provided the speed and higher resolution needed to help us accelerate our CMC development.  Now with Rebel in our tool kit, with its ultra-fast analysis of amino acids and vitamins, it will allow us to make real-time decisions to further accelerate our media development and optimization efforts and intensify our cell culture processes and push our continuous perfusion process beyond the 4 g/L-day that was recently announced and advance our Integrated Continuous Bioprocessing (ICB) platform." - said Dr. Christopher Hwang, HJB's Head of Platform Technology.

"HJB leads the way in deploying state-of-the-art tools in their biologics discovery and development workflows. It's exciting to take our collaboration with HJB into this next phase, and to see how ZipChip and Rebel can work in tandem to help drive that innovation," said Dr. Kevin J. Knopp, CEO and Co-Founder of 908 Devices.