Using an integrated data management system such as the IDBS Bioprocess Solution, supports organizations in identifying and improving a mammalian or microbial cell line’s desired production characteristics across the entire cell line development process, and how these cell lines behave in subsequent development steps.
Our workflows systematically capture process parameters, equipment and material details, instrument data, and cell line information while providing automatic calculations and visualization of results including full sample tracking. Inventory and Request management is an integral part of the solution and our workflows provide both the flexibility needed for early development and the comprehensive documentation needed for later development. The cell line development workflows include:
Our library of interoperable bioprocess workflows, based on scientific knowledge and designed to industry best practice, enables scientists to record and access all relevant product and process data within the same space; perform calculations in a reliable and repeatable manner and analyze image and numerical data together.
In combination with these features, scientists can utilize a consistent bioprocess ontology against which to store data and leverage the Audit by Exception functionality to empower organizations to gain significant improvements in operational run time, product quality and experimental quality. Moreover, the in-built management of biological and laboratory inventory facilitates better decision and troubleshooting by being able to manage the genealogy of cell cultures and other biological inventory, as well as bring together details of the samples, reagents and instruments with related processes and experiments.
Additionally, the IDBS platform allows for the integration of the different laboratory systems and lab instrumentation – data can be transferred from one system to another ensuring maintenance of data integrity and accuracy and inevitably streamlining the process in order to save the scientist time and effort.
Being able to trace a cell line’s lineage and development supports organizations in being able to generate high quality cell lines, develop high yields of biological product, and maintain adherence to ever-tightening FDA regulations. Organizations that choose to manage scientific data in a digital format acquire gains in contextualization and consistency of data, tracking of method variations and parameter variables and secure result capture.
This is particularly important in cell line development, as regulatory bodies require evidence of clonality of production cell lines. Without traceability to prove monoclonality, further procedures must be executed and any delays going to clinical trials can be enormously expensive.
All cell lines with the potential to be commercially available and ready for manufacturing need to be licensed, of which there are many types (e.g. commercial license, research license), depending on the degree to which the cell has been manipulated. At this point, full traceability and records of each process are crucial, as well as to ensure the protection of Intellectual Property (IP).
In short, The IDBS Bioprocess Solution can help Cell Line Development organizations streamline processes to reduce experimental reiterations, facilitate access to data to gain insight to the behavior and activity of the molecule within a cell line, as well as contribute to reducing expenditure through efficient and transparent data management. With software to navigate several regulatory pathways in parallel to conducting research at the bench, quality is put first to enable productivity.