Advances in biologics upstream processing
Improvements in cell culture media, feeding strategies, and cell lines have all contributed to modern high-productivity upstream processes. Process intensification, continuous perfusion, single-use systems, biosimilars, and growth in advanced therapies such as cell and gene therapies are all challenging upstream development teams to optimize existing techniques and investigate new technologies.
Yet for many upstream development scientists, data capture and reporting are still done in Excel. And not just for tracking cell viability and growth in shake flasks; even creating charts to compare online, at-line, and offline data for bioreactor runs typically involves several time-consuming and error prone transcription steps. Scientists simply need a better way of working to keep up with increasing demand for high-throughput techniques and enhanced analytics.
of the biopharmaceutical industry still uses paper, Excel or legacy systems to capture, store and analyze their biopharma development data.
These data management challenges across the product lifecycle are holding back the development of biologics, resulting in extended development times and higher development costs.
IDBS Polar BioProcess provides out-of-the-box workflows supporting process development and optimization from clone selection to final fill. For downstream, this includes filtration, chromatography, in-process adjustment, solubilization and refold, and fill/finish operations for mammalian and microbial expression systems.
Consistent and standardized data capture and automated calculations remove the burden and risks associated with manual transcription and improve data integrity, while maintaining the flexibility to support different methods and multiple runs in the same experiment. Integrated inventory management including buffer preparation, column packing and unpacking, and generation of process intermediates and samples ensures full traceability throughout development, supporting advanced reporting and root cause analysis. Within the chromatography workflow, details of column volumes and fractions created can be retrieved directly from ÄKTA UNICORN.
By capturing both process and analytical data at the point of execution, Polar BioProcess workflows deliver faster insights that improve process understanding and characterization. Out-of-the-box reports and interactive reporting tools ultimately support the preparation of essential documentation such as process descriptions, tech transfer documents and biologics license application (BLA).
Ready for a ‘fast data’ future?
Maybe it’s time to catch up with the other 14% who have already implemented efficient data management?
To find out more about the journey you and your organization could take to become part of biopharma’s data revolution, click here to take a copy of “What’s delaying BioPharma 4.0”.