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 upstream, this includes cell expansion, bioreactor, harvest (centrifugation/filtration), cell lysate preparation, and resuspension/wash for mammalian and microbial expression systems.
Integrated biological inventory management ensures full traceability throughout passaging for maintenance of cells and seed culture expansion as well as harvested cell cultures and sampling workflows. The same traceability applies to materials used such as media and feeds as well as equipment and instruments to support advanced reporting and root cause analysis. Consistent and standardised data capture and automated calculations remove the burden and risks associated with manual transcription and improve data integrity, while maintaining the flexibility to support culture splitting and pooling and multiple bioreactor runs in the same experiment.
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).
Maximize the productivity and scalability of mammalian and microbial cultures
IDBS Polar Bioprocess seamlessly integrates both process and analytical data throughout your workflows to deliver greater insight, enabling you to optimize upstream unit operations for maximum productivity. To learn more about Polar Bioprocess download our datasheet on upstream processing below!