How Developing Pharmaceutical Manufacturing Processes is like Writing a Cookbook
(Building a vendor agnostic, production-ready ontology)
The requirement:
The recipes used in pharmaceutical manufacturing (CMC) need to be developed and documented in a way that allows an identical product to be manufactured in different locations and potentially at different scales without sacrificing quality.
For years this has been supported by the ISA-88 standard, but a lot has changed in the thirty years since it was first published. A more flexible, comprehensive representation of the recipes is needed.
Our response to the need for change:
The Pistoia Alliance along with our member companies (MSD, Amgen, GSK, Eli Lilly, AstraZeneca and J&J) and implementation partners (CrownPoint & ZS) is well on the way to building a vendor agnostic, production-ready ontology for Pharmaceutical CMC (Chemistry, Manufacturing and Control) Processes supporting today’s data science and exchange needs.
Our completed Phase 1 has shown that a contemporary ontology is capable of capturing a more precise view of the processes used in pharmaceutical development and is able to facilitate data integration, exchange (tech transfer) and data insights. Specifically, we have shown that the ontology is capable of describing recipes and capturing data associated with runs allowing comparative analysis of different sites, equipment and scales (from a consumer stove baking a single cake to a commercial oven producing thousands of cakes for distribution).
Phase 2 is now well underway and is extending the ontology beyond simple small and large molecules, ensuring both extensibility and interoperability with related ontologies, and defining a governance structure for future sustainability.
This briefing:
Taking ontology to mean a structured framework that defines the concepts, entities, and relationships within a specific domain, enabling machines to understand and process information in a human-like manner the briefing covers:
- What we have learned so far.
- Challenges that lie ahead.
- Lessons of general application for developers of complex ontologies.