Why do biomanufacturing execution systems fail despite multi-million dollar investments?

In this episode of Out of the Lab, host Nicholas Crudele sits down with biopharma automation and manufacturing execution system (MES) consultant Robert Perks to unpack the realities of digitizing biomanufacturing workflows. From early R&D data integration to navigating the FDA’s shift toward Computer Software Assurance (CSA), Robert shares what it actually takes to achieve release by exception.

Key Topics Covered:

  • Cross-Functional Ownership: Why MES implementations fail when controlled by a single department.

  • CSV to CSA Shift: Moving away from binders of paper to risk-based critical thinking.

  • Designing for the Operator: Eliminating duplicated data entry and friction on the cleanroom floor.

  • Bridging R&D and Manufacturing: Leveraging early KPI and CQA data to build standardized Master Batch Records (MBRs).

  • Release by Exception: What infrastructure is required to make automated batch release a reality.

Timestamps:

  • 00:00:00 – Introduction & Operational Scope

  • 00:01:14 – What is an MES & Who Needs a Seat at the Table?

  • 00:03:12 – When Should Early Biotechs Engage with MES?

  • 00:07:55 – Operator Optimization & Reducing Data Duplication

  • 00:11:46 – The Regulatory Paradigm Shift: From CSV to CSA

  • 00:18:48 – Integrating R&D Data into Scale-Up Master Batch Records

  • 00:26:44 – The Holy Grail: Achieving Release by Exception

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