CMAB Biopharma (Suzhou) Inc., a company exclusively focused on delivering contract development and manufacturing services for biologics, said that it has successfully completed the development and manufacturing of QureBio’s bispecific antibody Q-1802 in only 9 months through its fully integrated platform. The filing package and drug product conforms to requirements necessary to submit INDs in both China and the U.S. Q-1802 is a bispecific antibody being studied for the treatment of solid tumors such as gastric cancer.
 
CMAB said it used a full complement of integrated services to complete the rapid development and manufacturing of Q-1802. Accelerated cell line development resulted in an expression level exceeding 4 g/L while parallel process and formulation development work saved time in the initial development phase. Pilot scale up allowed CMAB’s drug substance (DS) and drug product (DP) teams to complete three 200 L DS batches in single-use bioreactors and three corresponding lyophilized DP batches within the 9-month timeline. The last batch was performed under CGMP and is expected to be fully released within 2 months.
 
“Q-1802 is a bispecific antibody researched and developed based on QureBio’s own technology platform,” said Yejie Du, vice president and head of CMC, QureBio. “On the basis of maintaining a high level of bioactivity, it ensures that the bispecific antibodies are of good quality and of high output. The professional process development and project management team of CMAB worked closely with us to actively propose and implement solutions that enable us to quickly achieve important milestones and enable QureBio to gain a stronger competitiveness. The two parties will continue to work together to accelerate the dual IND filings in both China and the U.S., and quickly push the major products of QureBio to the clinical trial, bringing more effective drugs to the patients.”
 
Xiangdong Qu, founder, QureBio, said, “QureBio uses the concept of ‘Quality by Design’ to embed developability evaluation into early molecular design and evaluation. The smooth development of the project is the verification of this concept. The advanced integrated technology platform and coordinated project management capabilities of CMAB have prompted the efficient completion of the CMC of the project.”
 
Yongzhong Wang, chief executive officer, CMAB said, “Despite the recent challenges imposed by the ongoing pandemic, CMAB was able to deliver on our committed timeline while at the same time, protecting the safety of our staff. Based on our integrated biopharmaceutical development platform and technology, we are proud to have helped QureBio successfully complete their Q-1802 project, pre-clinical CMC process development and production. We are very glad to help innovative drug companies such as QureBio to advance their bispecific projects and hope it can benefit cancer patients as quickly as possible.”