HJB - Your Trusted Biologics CDMO Partner
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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.
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.
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.
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.
HJB is in full operation and the impact to your project during the Covid-19 pandemic will be minimized. We believe the pandemic of COVID-19 shall not slow down the development of your new drug.
At HJB, we believe the pandemic of COVID-19 shall not slow down the development of your new drug
Our facility is located in Hangzhou, Zhejiang province where there has been NO new local infection cases for the past weeks. All our site operations are normal.
Our supply chain is in reasonably good shape. We have been actively working with 3rd party sub-contractors and suppliers to minimize external uncertainty. At this moment, we do not expect material impact on lab supplies issues. Our proposed timeline, material generation or IND-enabling package, will not be affected.
We do suggest to our partners postpone near term on-site visit. Our China staff are not participating big conferences or meetings at this time. In the meantime, please be assured business discussion will go on as normal through TC, video conference and secured file-sharing system. And for us, local meeting can always be arranged.
The well-being of our employees is very important to us as well as your projects.
Up to now, no HJB employee or their family are infected by this virus.
In addition to strictly following government’s and CDC’s precautions which have been proved quite effective in controlling the spread of Covid-19 in China, HJB also carefully made and carried out its own set of SOPs and precautionary measures to avoid public transportation of the virus, including change seat deployment in our building to help keep social distancing, routinely executing strict sterilization procedure, and filtering the health status of all employees, contractors and visitors arriving and entering our building.
Since March China has generally got the spread of Covid-19 in control and the infection number is getting better every day. We trust with more and more strict measures being carried out in most countries, the situation will get better over the world.
We wish all the best for you and your loved ones, and looking forward to talk about your special projects. Let our industry seasoned experts to help your new drug projects keep moving forward during this hard time without compromising speed and quality.
Affected by COVID-19, HJB responded positively to the national and Hangzhou’s notices on disease prevention and control, adjusting timely the company’s operation and taking strict preventive and control measures. Currently, HJB has been approved to resume work on 11th February. Starting from 17th February, the company will arrange for employees to work on-site to ensure that the progress of the client’s project is minimally affected during the outbreak.
Recently, HJB once again delivered to client GMP samples, which will be used to apply for IND filing and clinical trials in both China and the US. During the process, HJB settled an unpredictable technical issue in scale up by maintaining professionality when providing services and leveraging its strong and comprehensive capabilities.
The project started in Aug. 2019. HJB provided scale up and GMP manufacturing services. Efficient internal coordination allowed HJB to finish process transfer and lab-scale process validation in just one month. However, it was later to be found that in 200L process scale up molecules were prone to degrade , which didn’t arise at lab scale and would endanger following GMP manufacturing.
The HJB team immediately discussed the unexpected issue both internally and with the client. To solve it, the team compared and analyzed the processes involved including their operational details, and designed multiple tests to examine the particulars. Although analytical and testing methods were not transferred in this project, the complete analytical platform and rich experience allowed HJB to pinpoint the root cause of the issue in merely a week by testing and analyzing samples from the scale up batch.
To ensure product quality in the GMP batch and client’s timeline for IND filing, the HJB team came to a solution to improve the manufacturing conditions in scale up of havest, HCCF pool hold and protein A pool hold, aiming minimize molecule degradation. Consequently, HJB initiated and completed the GMP manufacturing according to the original timeline. By reinforcing staffing, cutting down procedures and time for storing intermediate products, and keeping track of the quality attributes of samples in the process, all the product quality parameters were up to standards.
The Head of the client’s technical team said, “We are very happy with the results. HJB was able to address the issue in scale up and met our project timeline by excellent communication skills and coordination. It was very important for us to get a leg up on the fierce competition. We appreciate that HJB paid great attention to our project and expect more cooperation in the future.”
HJB’s Director of Manufacturing and manager of this project Steve Chen said, “Our CDMO business has always been to focus on the needs of our clients and solve problems. I am glad that the HJB team could solve the technical issue in the project with efficiency and learned from this experience to improve ourselves. In the future, we will leverage our professionalism and technical strengths and create values for more partners.”
HJB is dedicated to providing comprehensive services for partners. Equipped with leading technologies that include Integrated Continuous Bioprocessing platform and flexible manufacturing modules T-BLOC, HJB can meet diversified demands on drug development and manufacturing. We will continue to strengthen our drug development and manufacturing competence and production capacities to provide high quality, reliable and efficient CDMO services to more partners around the world.