Bioprocessing technologies need to be able to speak to each other more effectively, according to U.S. National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) researchers, who say drug firms will only reap the full benefits of digitization when information can flow between unit operations.
In “digital manufacturing,” data collected at each unit operation, inform and control subsequent stages of the process. The critical factor is “interoperability,” which is the ability to transfer this information from one step to the next in a usable form.
And interoperability is where biopharmaceutical companies often struggle, according to Roger Hart, PhD, big data program lead at NIIMBL.
“Different companies within the biopharmaceutical manufacturing sector have different levels of digitization maturity. All companies are composed of divisions and departments with legacy data systems, which contribute to the difficulty of achieving enterprise-level interoperability.
“Digital interoperability within and between enterprises requires canonical data schema and ontologies which are communally created by consortia and standards organizations,” Hart tells GEN.
Ontologies
To that end, Hart and colleagues have developed a set of concepts, or ontologies, to help drug companies ensure the manufacturing technologies and systems they use can exchange data as effectively as possible.
The ontologies, which are available through OAGi, are a reference framework for systems integration, data analytics, regulatory submissions, and digital transformation initiatives, Hart says, citing digital twins as an example.
“Fast, efficient, and reliable operations require that the right high-quality data be available when and where needed. Digital twins, for instance, require extensive and fast interoperability among the real-world sensing and control devices, interfacing systems, and users to be effective,” he says.
NIIMBL and OAGi developed the ontologies in partnership with various drug manufacturers and technology suppliers. And, going forward, input from such companies will help revise the schema, according to Hart.
“Many leading biopharmaceutical manufacturing and technology and supply companies, including AstraZeneca, Merck Sharp & Dohme, Merck KGaA, and MilliporeSigma, have contributed to the creation of the currently released ontology elements, and many others continue to mature the ontology in the NIIMBL and OAGi partnership,” he adds.
Some contributors are already using the new ontologies to improve interoperability in their manufacturing operations.
Hart says, “EMD Group is making use of the BioPharma ontology with their BioTech Development Center to standardize and align process and analytics data across different scales and sites. This enables experts to easily access high-quality interoperable data, dramatically speeding up the tech transfer and process optimization component of biomanufacturing.”