Taiwanese firm TaiMed Biologics announced this week the US Food and Drug Administration (FDA) has approved its monoclonal antibody drug ibalizumab (TMB-355) for treatment of HIV/AIDS infected patients on expanded access for HIV/AIDS.
The manufacture of ibalizumab is “a bit more challenging” than for other mAbs, WuXi spokesman Chris Chen told Biopharma-Reporter.com, with solid expertise in NS0 cell culture development and scale-up required.
“Taimed went through a rigorous selection process for manufacturing partners,” he told us. “Major CMOs such as Lonza and Boehringer Ingelheim were in the bidding processes. Wuxi was finally selected due to our technical excellence, high quality and competitive cost.”
The mAb will be manufactured for additional clinical trials from WuXi’s biologics manufacturing facility in Wuxi City, China, completed last year and – according to Chen – represents a landmark in Chinese biomanufacturing.
“For Mabs, the facility we built is the first in china to meet global standards, therefore it is a milestone for the Chinese Biologics industry,” he told Biopharma-Reporter.com. This followed a successful scale-up of the process in disposable bioreactors last October, which was also a first in the global biologics industry, according to Chen.
Furthermore - as another landmark - the FDA approval is the first reported for a sterile biologics product manufactured in China for use under a US IND.
Chinese biologics and global quality
For contract manufacturing, China has established itself – along with India - as a global supplier of small molecule APIs. However, we asked Chen if this milestone represented a shift to larger molecule contract manufacturing in China.
Whilst “companies in china are aggressively investing in biologics,” he told us “there is no flurry of companies in China who can manufacture mAbs in global quality. Wuxi is the only one!”
He also spoke of the challenges in large molecule manufacturing, saying most Chinese companies still lack a “solid technical expertise and extreme level of quality.”
Wuxi – who in January predicted a surge in demand for biomanufacturing services – “invested heavily in recruiting the best talents to build world-class manufacturing and quality organizations to enable the successful completion of this Taimed project,” he said.