Setting The Stage For Electronic Data Exchange

By Stephen Wing, Senior Product Manager, Analytical and Logistical Services

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. The vision offered by Bioprocessing 4.0 is a manufacturing ecosystem, seamlessly connected via uninterrupted data acquisition and analysis and characterized by information transparency and decentralized decision making. Drug manufacturers will be able to control and understand every aspect of their operation, leverage immediate access to data to boost productivity, increase operational efficiency and drive growth more effectively and efficiently.

Adoption of an electronic format for the exchange of data (referred to as eData) from suppliers of raw materials to biopharmaceutical manufacturers is an important step towards making Bioprocessing 4.0 a reality.