Insourcing cell-line development has helped a fast-growing antibody manufacturer to deliver process improvements and strengthen communication with their contract manufacturer, according to Genmab, based in Denmark.
The company says its choice to insource cell-line operations, rather than relying on a CDMO, helped them accelerate cell-line development and improve their antibody titers.
“We’re interested in new technology and, by insourcing and freshening up our processes, we’ve stayed on the cutting edge, achieving timeline and cost savings, as well as increasing titers,” explains Rick Hibbert, PhD, vice president of chemistry, manufacturing and controls (CMC), science & technologies, adding that part of the motivation for insourcing was that Genmab now has the resources to do cell-line development. “As a smaller company, it made a lot of sense to rely on a CDMO. But we’ve grown a lot over the years and, at this scale, it’s easier to do ourselves.”
Watching the speed of process development that happened during the COVID-19 pandemic inspired his team. “We wondered to what extent these timeline improvements could be applied to oncology and, therefore, accelerate our delivery of products to patients,” explains Hibbert.
Having brought the processes in house, they decided to work on improving titers, focusing on using transposons to better target plasmids to the correct location in the host cell genome, reducing the instability of their clones.
“We’d had static titers for years. But, through targeted integration, we achieved significantly higher titers while needing to screen fewer clones, streamlining our processes,” he continues.
With random integration, the company would have 25% unstable clones and would end up with the lead candidate clone being unstable. The team would need to duplicate work on a backup clone and, if this also proved unstable, it could slow timelines significantly.
Hibbert also reports that, while developing their own inhouse processes, they were able to use design of experiment (DoE) to discover that a temperature shift could improve yields. He calls this a “quick win.”
Finally, to his surprise, bringing analytics in house has helped them communicate better with their manufacturing CDMOs.
“We have lots of historical data, which helps us build trust,” he points out. “By controlling our platform better, we have a good data package and CDMOs don’t have to do redundant work, and validation can be completed on shorter timelines.”
The post Insourcing Cell-line Development Streamlines Antibody Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.
The company says its choice to insource cell-line operations, rather than relying on a CDMO, helped them accelerate cell-line development and improve their antibody titers.
“We’re interested in new technology and, by insourcing and freshening up our processes, we’ve stayed on the cutting edge, achieving timeline and cost savings, as well as increasing titers,” explains Rick Hibbert, PhD, vice president of chemistry, manufacturing and controls (CMC), science & technologies, adding that part of the motivation for insourcing was that Genmab now has the resources to do cell-line development. “As a smaller company, it made a lot of sense to rely on a CDMO. But we’ve grown a lot over the years and, at this scale, it’s easier to do ourselves.”
Worked on improving titers
Watching the speed of process development that happened during the COVID-19 pandemic inspired his team. “We wondered to what extent these timeline improvements could be applied to oncology and, therefore, accelerate our delivery of products to patients,” explains Hibbert.
Having brought the processes in house, they decided to work on improving titers, focusing on using transposons to better target plasmids to the correct location in the host cell genome, reducing the instability of their clones.
“We’d had static titers for years. But, through targeted integration, we achieved significantly higher titers while needing to screen fewer clones, streamlining our processes,” he continues.
With random integration, the company would have 25% unstable clones and would end up with the lead candidate clone being unstable. The team would need to duplicate work on a backup clone and, if this also proved unstable, it could slow timelines significantly.
Hibbert also reports that, while developing their own inhouse processes, they were able to use design of experiment (DoE) to discover that a temperature shift could improve yields. He calls this a “quick win.”
Finally, to his surprise, bringing analytics in house has helped them communicate better with their manufacturing CDMOs.
“We have lots of historical data, which helps us build trust,” he points out. “By controlling our platform better, we have a good data package and CDMOs don’t have to do redundant work, and validation can be completed on shorter timelines.”
The post Insourcing Cell-line Development Streamlines Antibody Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.