Contract Pharma Staff09.01.20
HJB, a biologics contract development and manufacturing organization (CDMO), has entered into a partnership for CMC development and manufacturing with Ansun Biopharma on its therapeutic biologics pipeline. The first program is expecting to submit an Investigational New Drug (IND) application in 2021.
Ansun will have the ability to leverage HJB's 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.
"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, chief technology officer, 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."
Jerry Yang, general manager, HJB, "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. 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 and delivered 30 batches of GMP products. 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.
Ansun will have the ability to leverage HJB's 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.
"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, chief technology officer, 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."
Jerry Yang, general manager, HJB, "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. 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 and delivered 30 batches of GMP products. 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.
