So far the very document-driven method of bioprocess development has been hugely inefficient. Collecting data and putting it into a vault may tick a box on a worksheet but does not fundamentally improve the organization.
With secure validated access to up-to-date experimental and process data, stage-gated, versioned reports can be generated quickly by a query rather than pulling data from multiple documents, which a majority of biomanufacturers still have to do today. This is where data management overtakes legacy document/paper management.
Rather than living in a document-heavy environment, fast-moving bioprocess organizations can now take advantage of a flexible, less expensive data-driven world with documents generated on demand. Into this data-centric environment, modular enterprise ELNs (such as IDBS’ E-WorkBook) provide a data management platform combining the flexibility needed for research with the ability to lock down and validate procedural execution workflows.
Integrated with the design of experiments systems, such as those from Umetrics, and internal historian systems, these platforms are able to capture, compute, compare, and secure process data. They then integrate upstream to enterprise requirements planning systems, such as SAP.
Companies such as Lonza have considered process technology transfer during a selection of enterprise data-management systems. As a result they have already seen benefits in improved quality, faster design transfer, and an increase in operational effectiveness. In the bioprocess area, and particularly for CMOs, where costs are well understood, these savings can reach the bottom line quickly.