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.