Bioprocess researchers undertaking high-density mammalian, bacterial or microbial cell culture separations can now benefit from a next-generation single-use, sterilised, closed-system BioProcess Container (BPC) designed to offer a highly efficient alternative for harvesting by centrifugation.
Developed specifically for use with the Thermo Scientific Sorvall Bios 16 Centrifuge, the single-use, sterilised, closed-system CentriPak BPC enables optimal protection of critical sterile liquids from cross-contamination typically associated with reusable containers. The new system can be used to process culture volumes of between 3 and 500 L, facilitating high-throughput and high-efficiency cell biomass or clarified supernatant harvesting to maximize laboratory productivity. Furthermore, there are no time-consuming, labour-intensive and costly preparation and post-use cleaning steps involved.
"Filtration — which is commonly used in cell culture applications — poses a number of challenges, the most crucial being the technology is not suitable for handling microbial or bacterial cells, while also requiring constant process monitoring and unplanned interruption due to fowling," explains Carlos Sevilla at Thermo Fisher Scientific. "Combined with our centrifugation technology, the new CentriPak BPC has been designed to overcome these challenges, offering a next-generation centrifuge container and space-saving solution, that maximises sample safety and enables faster turnaround times to expedite the development of new cell therapies and biologic treatments. In addition, the new product is manufactured using industry-accepted films and following current good manufacturing practices (cGMP) standards that enable customers to rapidly validate the systems in their processes."
To ensure it meets the high-quality standards expected in the bioprocessing industry, the CentriPak BPC is subject to thorough quality control procedures, in compliance with cGMP and ISO 13485:2016. Thermo Fisher’s rigorous production control process provides complete lot traceability for each batch, with relevant documentation accompanying the lot through every step of the manufacturing cycle. At the end of the process, the Certificate of Analysis provided with the CentriPak BPC reports compliance of all product contact materials and films to USP<88>, USP<87>, USP<661>, EP<184.108.40.206> and EMEA/410/01. Routine testing is performed on representative samples in periodic validations for USP<85>, USP<788> and ANSI/AAMI/ISO 11137.