The two 3,000 L stainless steel bioreactors will mainly target market supply at the company’s site in Laupheim, Germany, and are expected to be operational in early 2017.
The company defended its investment in stainless steel, as opposed to single-use, by noting that manufacturing in stainless steel “is far from being outdated,” especially for market supply and late clinical phases.
The twin-bioreactor system is designed for running two main bioreactors in parallel with one shared downstream processing unit to provide higher throughput while reducing labor costs. The system will integrate with the existing 3,000 L GMP line and will more than double the production capacities for cell culture-derived proteins at Rentschler.
What’s unique is that the twin system will allow the company to run cell culture processes in fed-batch mode with a high output in a single suite.
“The expansion will strengthen our global competitiveness and increase our market awareness of being a CMO partner of first choice all the way down from early clinical trials up to approval and market supply with a wide range of manufacturing technologies to offer,” said Frank Ternes, Chief Business Officer at Rentschler.
The expansion comes as the company doubled its capacity last month by adding a 2,000 L single-use bioreactor to its German facility, which it expects to go live in the first quarter of 2015.
In the last few years, Rentschler has been heavily investing in other single-use technologies, according to the company.