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

Company News

31Mar, 2020

HJB is in full operation and the impact to your project during the Covid-19 pandemic will be minimized

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.

17Feb, 2020

HJB Resumes Work to Safeguard All Projects

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.

20Jan, 2020

HJB Swiftly Delivers GMP Samples by Solving Conundrum in Degradation of Molecules

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.

17Jan, 2020

HJB Achieves Major Milestone in Continuous Perfusion Cell Culture Platform to Provide Industry Leading Productivity and Speed to Manufacturing

Dedicated to innovative process and continuous manufacturing of biologics and providing high quality, reliable and efficient CDMO services to partners, HJB today announced it has achieved a major milestone in its continuous perfusion cell culture platform by achieving volumetric productivities of > 4 g/L per day for multiple cell lines expressing monoclonal antibodies.

31Dec, 2019

HJB and Elpiscience Reach Strategic Partnership

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.

19Dec, 2018

HJB Announces Milestone by Helping Lepu Biotech Advance Clinical Trials Progress

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.

01Nov, 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.

01Aug, 2018

HJB Completes First Batch of GMP 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 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.