A majority of biomanufacturers will adopt continuous bioprocessing in some form within five years. That’s the prediction of Chris Hwang, PhD, CTO at Transcenta Holding, who spoke exclusively to GEN about a talk at Bioprocess International (BPI) US West earlier this year.
“There are many benefits of continuous processing but, as with single-use systems, its adoption has been slow because, among other reasons, biopharma is a heavily-regulated and risk-adverse industry,” Hwang says.
Companies want to ensure their adoption of continuous processing doesn’t disrupt their product development or approval by health authorities, Hwang explains. However, with the FDA and EMA, among others, supportive of continuous processing, he predicts adoption will ramp up within the next five years.
Transcenta says it has invested in in-house media and a continuous perfusion platform, alongside developing and implementing a continuous downstream process. According to Hwang, his team has demonstrated more than 10-fold increases in output using their continuous perfusion platform when compared to the same cell lines in conventional fed-batch processes.
The company claims that, at the BPI presentation, they also showed a volumetric bioreactor productivity of more than six grams per liter per day, in a 30-day culture, without compromising process control or product quality.
Transcenta partnered with Merck KGaA in 2020 to co-develop continuous downstream technology, with the aim of implementing an automated and continuous upstream and downstream process for GMP manufacturing at their manufacturing site in Hangzhou, China, by 2023, he says.
“Our strategy is to implement continuous processing in phases rather than going ‘all-in’ on end-to-end continuous,” explains Hwang. “From a development point-of-view, we need to identify and manage our risks carefully. If we go into fully continuous processing from the get-go, I feel it will impose significant risks to our manufacturing and to pipeline development.”
According to Hwang, continuous processing is not an end goal for Transcenta, but merely a step towards maximizing its benefits. In addition, he argues that the continuous processes they’re deploying aim to be simple and robust.