Transcenta claims perfusion-based mAb production 'milestone'

Transcenta says efforts to intensify perfusion-based mAb production platform should give it competitive edge.

It made the claim last week, also announcing that tweaks to its perfusion platform allowed it to increase productivity to greater than 4 g/L per day for multiple cell lines.

Such intensification is key to Transcenta’s competitive strategy according to CEO Xueming Qian, who citied demand for sustainable supply of lower cost, higher quality medicines as key.

Image: iStock/eugenesergeev

“With drug pricing and affordability at the top of the agenda of the pharmaceutical industry, it is critical to be able to shorten the development cycle and reduce the cost of goods for biological products.

“The ability to combine continuous bioprocessing technology with our modular manufacturing facility T-BLOC to ensure drug supply is a significant competitive advantage,” he said.

Intensification

Transcenta claims that using its approach a 500 L bioreactor can produce 400 kg of drug substance a year, which it says is around 10 times the output of conventional fed-batch processes.

According to Transcenta chief technical officer Chris Hwang, the productivity increase was achieved using culture media developed in-house combined with the firm’s expression system.

“Perfusion technology has been used to produce biologics since early 1990’s but mainly for production of labile and harder to manufacture proteins.

“However, at Transcenta, we are dedicated to intensify this technology to develop a highly productive platform that is fast to develop and can be applied to any protein biologics with enhanced product quality control,” Hwang said.

He added, “I’m so proud of our team in achieving this important milestone in mere 12 months of development and I firmly believe there is still significant upward potential and is excited with what is yet to come.”

Pipeline

Transcenta was founded in 2019 through the merger of HJB and MabSpace Biosciences.

At the time the firm said its aim is to shorten the timeline from target to BLA and make its GMP facility to support development and commercialization of both in-house and strategic partner’s pipeline molecules.

According to Transcenta’s website, in-house candidates include mAb-based treatments for cancers and osteoporosis, the most advanced of which are in Phase II development.

The firm’s partners include Eli Lilly from which it licensed Chinese commercialization rights to a portfolio of biotherapeutics for bone diseases, which include the Phase II candidate blosozumab.