The Digital Solutions Offering Complete Control over Bioprocessing Workflows
Industry Insight Aug 28, 2018 | by Karen Velardi, Thermo Fisher Scientific
Robust data management is integral to both academic researchers and scientists in the pharmaceutical industry, especially for those working with bioprocessing workflows. To ensure products are of a consistently high quality, scientists must develop streamlined processes for each stage of a bioprocessing pipeline, and monitor them to continually drive optimum performance. Typical bioprocessing workflows can be complex, involving upstream processes such as cell isolation, growth and cultivation stages, as well as downstream processes from product harvest to purification. While each of these steps is executed independently, the free flow of information between users is essential for the generation of high quality products.
Bioprocessing workflows must be carefully monitored to ensure the correct conditions and materials are used from start to finish. Upstream issues can easily affect downstream processes, rendering an entire batch unusable. Cell culture media, bioreactor conditions and cell lines will all affect cell health and product output. The use of incorrect CO2 and pH levels, or erroneous cell count and viability measurements, could cause delays in product harvesting or even poor yields.
Organizations must connect the steps involved within their bioprocessing workflows, taking care to monitor system performance by recording properties such as instrument parameters, production levels and product purity measurements. This level of detail is not only important to drive efficient processes, but also necessary to comply with regulatory guidelines that require meticulous data management and full audit trail transparency. Guidelines set by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the International Council for Harmonization (ICH) include recommendations around the adoption of quality by design (QbD) methodologies and use of key metrics such as stability studies, impurity testing and product quality monitoring based on Good Manufacturing Practice (GMP) risk management. Ensuring the highest levels of data integrity for every piece of information collected can make the difference between successful outcomes and inferior products, the latter risking more intense regulatory scrutiny and company audits.
The introduction of digital science solutions to the modern lab is transforming bioprocessing workflows by providing scientists with full control over procedures, data integrity and compliance. By providing visibility at any point along a bioprocess stream, integrated digital platforms are increasing workflow awareness and enabling scientists to easily evaluate and adjust workflow processes. These platforms provide a basis on which bioprocessing workflows can be monitored, and data can be collected and reviewed. This allows scientists, for example, to sign off approved batches, which can be quickly taken forward by others further downstream as batch quality has been unambiguously confirmed.
Building bioprocessing applications on top of these digital platforms delivers an additional level of control by allowing scientists to organize every process individually and then integrate processes into a comprehensive workflow automatically. Applications can be designed to track materials, reagents, conditions, instruments and more, with the data incorporated into one system for easy management and full traceability. From bioreactor optimization apps that monitor reactor conditions and cell growth data, through to large-scale biologics purification programs that analyze protein purification and filtration steps, digital solutions can be used to standardize protocols, track product batches and optimize processes. Operating with greater control and visibility in this way can help organizations achieve higher levels of product quality and demonstrate regulatory compliance more easily.
By providing scientists with a platform to build robust bioprocessing workflows, digital science solutions are helping organizations achieve complete regulatory compliance while delivering high quality outcomes. Using integrated process monitoring applications that can deliver complete sample tracking across experiments, assays and processes, these solutions are driving the development of more flexible workflows that operate with the highest levels of data integrity.