Headquartered in Düsseldorf, Germany, GEA Process Engineering manufactures designs and develops processing systems for the biomanufacturing industry, boasting the likes of Roche, Merck Serono and Sanofi-Genzyme among its clients.
At this year's TechnoPharm show in Nuremberg this week Biopharma-Reporter.com spoke with Dirk Hetzel, sales director for pharma and biotech, about the shift from batch-fed to continuous manufacturing form biologics production.
“For cell culture manufacturing, continuous is the industry standard,” in the upstream process, he told us, with perfusion technologies allowing the feeding and harvesting of biologics like monoclonal antibodies to run for several months at a time.
This differs from microbial production, he continued, which is almost entirely done in batches that run for 2-3 days.
“Continuous is the best solution to make mAbs at the moment,” he said, mentioning GEA had implemented such technologies at Roche’s plant in Penzberg, Germany and Merck Serono’s in Corsier-sur-Vevey, Switzerland, which boasts approximately 20 bioreactors “from 20l up to 15,000l all in stainless steel.”
Shift to Asia
“Due to the interest in monoclonal antibodies (mAbs), we have seen continuous manufacturing being taken up more and more in the last four or five years,” Hetzel continued, adding the adaption of perfusion technologies will increase as mAb production increases globally.
“I think it will grow in the next years but more in Asia Pacific,” he said, due partly to lower production costs.
“We have realized there is a shift [in biomanufacturing] from Europe to Asia and a lot of Asian companies are starting with mAbs… all the global players like Roche, Novartis, Lilly etc have joint ventures with Chinese companies or their own operations to make mAbs in China.”
Currently GEA offers fermentation for the upstream and certain areas of downstream production, such as centrifuge systems and homogenizers through its subsidiaries, Westfalia and Soavi respectively.
“We can deliver the complete process from different GEA companies,” Hetzel said though added GEA did not at present offer its own chromatography solutions.
“This isn’t in our portfolio but sometimes we work with other companies and make a complete process integration.”