Raw data – a 4.0 approach to materials offers process development benefits

Biopharmaceutical raw material characterization stands to be revolutionized with robust data mining and collaboration among producers, suppliers and vendors.

This Biopharma 4.0 approach – the convergence of information technology, operational and processing technologies – is particularly well suited to highly complex raw material supply chains. Tracking the flow of materials from manufacturer to wholesalers and distributor, across multiple countries, is a significant challenge.

Claudia Berrón, Avantor’s Senior Vice President, Business Development and Commercial Operations, spoke with GEN: Genetic Engineering and Biotechnology News and shared her thoughts on the best application of Biopharma 4.0 thinking.

For instance, the use of pre-weighed powder and liquid materials in single-use systems. Traditionally these materials are delivered in bulk and, when received, need to be quality assured and then sub-divided before use. But, pre-packaged materials, delivered in single-use packages with digital documentation of the material, could help streamline the manufacturing process.

Collaboration and transparency are key to the effort to improve processes, Berrón said.

"Gaining such in-depth visibility from suppliers driven by strong collaborative efforts gives biopharma manufacturers the ability to more accurately assess and predict the process performance of any given raw material ahead of its use."

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