Biovian is pleased to present its two newest investments in capacity: the new 200 L Wave Bioreactor for mammalian cell culture and the new 300 L Stirred Tank Bioreactor for microbial fermentation. “Biovian has invested in new technology again and has increased capacity to support our customers even more in their challenging R&D processes,” says Dr. Knut Ringbom, director of projects and marketing at Biovian.
The wave bioreactors are used in mammalian cell culture, typically producing antibodies or other recombinant proteins for clinical trials. The advantages of the disposable wave-bag technology are fast campaign changes, low cleaning and maintenance costs, and high production yields. By using high-producing cell lines, combined with fed-batch or perfusion technologies, the material demands for clinical trials can be fulfilled even under stringent timelines.
Biovian has worked with disposable bag wave bioreactors for a number of years and has gained the necessary expertise and experience required to use this technology effectively. This has enabled Biovian to provide customers with cost effective services in the production of clinical trial material within demanding time frames.
The new 300 L Stirred Tank Bioreactor will bring versatility to Biovian’s microbial fermentation production capacity. Combined with the earlier, existing fermentation capacity, a faster throughput of clinical batches and the possibility to handle multiple microbial projects simultaneously, are some of the main advantages brought in by the new 300 L Stirred Tank Bioreactor.
“We are very pleased to see this new capacity and technology being made available to our customers,” says Dr. Pirkko Kortteinen, director of manufacturing and development at Biovian. He continues: “We are using state-of-the-art technology combined with the expertise of our highly skilled staff. As an example, Biovian is in the front line in taking the wave technology in use.” This increase in production capacity improves the ability of Biovian to serve its customers.
In parallel with the increase of mammalian cell cultivation and microbial fermentation capacity, Biovian has expanded its contract manufacturing license to also include contract quality control analyses. Biovian’s contract analysis licence authorises Biovian to perform drug substance and drug product analyses for qualified person (QP) release purposes. The service offered includes protein analyses, cell based assays, sterility test, endotoxin test and other microbial impurity assays. These quality control analyses are performed according to Ph.Eur. and USP as required.
“This service is an important addition to our portfolio of services as a CMO,” says Dr. Knut Ringbom, from Biovian, continuing, “It brings added value to our customers by offering them the one-stop-shop concept.”