Every day, drug manufacturers must consider and address a wide range of challenges and prospects including complex regulatory requirements, intense cost pressures and the business opportunities offered by novel product classes. Transforming biopharmaceutical manufacturing with integration of intensified, continuous, predictive and autonomous operations is one solution that holds promise for streamlining operations, exploring new therapeutic modalities and meeting regulatory expectations which continue to evolve.
Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which the industry will leave behind paper-based procedures, data silos, manual process control and equipment that cannot communicate with each other.
Adoption of a standard eData platform accelerates and facilitates sharing of raw material quality data and enables the end user to integrate data directly into internal knowledge management systems and process analytical tools. This allows for improved monitoring and analyses of production performance, better understanding of raw material impact to process and product variability, and more efficient investigations process for out-of-spec situations.