Sartorius Stedim Biotech (SSB) and Nova Biomedical agreed to combine the latter’s BioProfile® FLEX2 cell culture analyzer with SSB’s ambr® multiparallel bioreactor systems to generate a platform that can simultaneously run, sample, and analyze huge numbers of cell culture conditions for high-throughput cell line, media, and process development by design of experiments (DoE), as part of the quality by design (QbD)-led process development approach.
SSB’s ambr® platform, built on microscale technology developed by SSB’s TAP Biosystem operation, is designed to mimic the characteristics of classical bioreactors at the microscale, by allowing automated parallel processing of single-use bioreactors. Integration of ambr and the BioProfile® FLEX2 will provide the capability for independent sampling, sample transfer, analysis, and automated feedback control in each mini-bioreactor, the firms claim.
SSB and Nova aim to deliver fully integrated analytics for both the ambr 15 cell culture system and the high-throughput ambr 250 system during 2017. The ambr 250 is the firm’s new bioreactor system for parallel fermentation or cell culture, which uses 100-mL to 250-mL single-use bioreactors, controlled using an automated liquid-handling system.
“The integration of BioProfile FLEX2 with the ambr cell culture systems will result in accelerated commercialization of products and the ability to develop more products at lower cost, while ensuring the best quality of biotherapeutics for patients worldwide,” stated Nicholas Theodore, svp for global sales at Nova Biomedical. “The combination of the ambr and Nova’s BioProfile FLEX2 solutions saves time by significantly increasing the amount of data that can be generated per run,” added Stefan Schlack, svp for marketing and product development at SSB. “Together with our Umetrics and BioPAT® MFCS software suites, this will offer a complete solution to generate and analyze the vast amounts of data required for a QbD approach to upstream bioprocess development.”
Nova Biomedical’s Profile FLEX2 automated cell culture analyzer can handle up to 16 cell culture tests, including chemistry, viable cell density, and osmolality. The platform exploits Nova’s MicroSensor Card™ technology, which negates the need for chemistry sensor maintenance while increasing analyzer speed and reducing sample volume, and is designed to negate the need for chemistry.