Advances in biologics downstream processing
The focus of biopharma development has recently seen a shift to downstream processing. Its rejuvenation as an area for focus has multiple drivers: high-productivity upstream processes, interest in continuous bioprocessing, development and manufacturing of biosimilars - and growth in advanced therapies such as cell and gene therapies - are all challenging downstream development teams to optimize existing techniques and investigate new technologies for biologics purification.
Yet, for many downstream development scientists, the majority of data capture and reporting is still done in Excel files. Not only does this create data integrity challenges, it also makes it very difficult to realize the benefits of bioprocess modeling and data analytics. Creating charts to compare chromatography traces from ÄKTA UNICORN runs with HPLC data from sample analysis, for example, typically involves a number of time consuming and error prone transcription steps.
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.
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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).
Optimize unit operations for effective product recovery and purification
High-productivity upstream processes, continuous bioprocessing, biosimilars, and growth in advanced therapies such as cell and gene therapies are all challenging downstream development teams to optimize existing techniques and investigate new technologies for biologics purification.
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.