A Continuous Confidence Boost
Higher productivity, lower hold times, lower costs... Continuous processing of monoclonal antibodies could offer a number of advantages, but regulatory uncertainty and upfront investment remain sticking points. As increasing numbers of case studies emerge, the industry looks set to receive the confidence boost it needs to facilitate widespread adoption.
Gong Wei |
sponsored by GE Healthcare
In May 2019, GE Healthcare brought experts together at its Uppsala site in Sweden for “Bioprocess Days.” With a focus on the future of bioprocessing, one key theme of the event was continuous biomanufacturing. Here, we present an article based on an interview with Wei Gong – Director at Henlius Biotech, Shanghai – who presented a case study on “Continuous Manufacture in mAb Production.”
The monoclonal antibody (mAb) field has exploded over the past few years. Case in point; 21 of the 81 mAbs approved since 1986 came in 2017 and 2018. In fact, 49 percent of all global drug sales in 2017 were for antibody drugs – a remarkable statistic. The industry appears to set to continue its upward trajectory, with one analysis projecting a compound annual growth rate of 6.3 percent to reach $131.8 billion by 2023, from $91.1 billion in 2017 (1).
As the biopharmacetuical industry matures, it has been debating which next wave of new technologies will further enhance industrialization of the sector, with the main goals being to improve manufacturing speed, flexibility, and quality, while reducing costs. To that end, several companies, including Henlius, have been evaluating connected and intensified bioprocess steps – and considering how a fully continuous process may look in the future.
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