Biopharmaceutical manufacturers generate and collect massive amounts of data – from incoming material information, quality control results, LIMS, QMS, MES systems, and unit operation sensors. Yet, due to data silos, disparate data formats, data governance issues, and other factors, 70% of bioprocessing data goes unused.
Because better process understanding and improved product quality requires greater use of data, the industry is adopting data visualization and analysis tools together with technologies such as data lakes, cloud computing, augmented or virtual reality (AR and VR), and predictive analytics.
To avoid time-consuming, manual efforts, biotech companies need smart data management tools that automatically collect data from disparate sources such as manual records, spreadsheets, external databases, and machine data, and then aggregate it into an analysis-ready format. To this single dataset, biomanufacturers can now apply data analytics, visualizations, and process monitoring technology that improves product quality and optimize processes.
Bio4C ProcessPad™ software is a data visualization, analytics, and process monitoring platform which allows you to easily acquire, aggregate, and analyze bioprocessing data.
Bio4C ProcessPad™ software is a data collection, visualization, and analytics platform that enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
To promote the use of state-of-the-art technologies while ensuring that these new software solutions meet the safeguards and regulations of traditional paper-based record keeping, the FDA issued 21 CFR Part 11 regulations to establish standards under which new electronic documentation and electronic signatures are regarded trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper.
The bioprocess lifecycle for any therapeutic protein includes a complex series of upstream and downstream activities starting with drug development followed by manufacturing, quality release and finally shipping the drug to the market.
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