Emerson and Roche Collaborate on Digital Modality Library for Pharmaceutical Development
In collaboration with Roche, one of the world’s largest biotechnology companies, industrial technology company Emerson has developed a digital library of modalities for faster deployment and use of Emerson’s DeltaV Process Knowledge Management (PKM) software. Emerson said this library of modalities will “minimize the time it takes to develop a process specification through its lifecycle to full commercial scale.”
This is a key development, according to Emerson, because it can take months to establish a life sciences organization’s standards and then create validated building blocks using the PKM collaboration environment. Users have to align on an ontology, equipment classes and capabilities, use of materials and formulations and quality testing plans before they can begin creating process specification recipes. All of this must also be aligned with the submission and licensing process within the global supply chain.
Technology transfer of this type is a major obstacle in delivering new medical breakthroughs to patients globally. Emerson said this specialized library will help life sciences companies overcome this hurdle by streamlining and accelerating the move from research to commercial launch.
Emerson’s PKM software is designed to replace manual methods with a structured repository to define the process specification as well as a collaborative digital platform to manage changes as a specification evolves during the process development lifecycle. This standardization process of specification elements and relationships helps life sciences companies more rapidly deliver treatments, Emerson said.
More specifically, the DeltaV PKM Modality Library provides a set of software building blocks to help users quickly establish a modular approach to characterizing process definitions. The library’s pre-built, proven and customizable set of specification elements provide are already established for a given modality. This includes examples of underlying process steps, activities, key process parameters and critical quality attributes.
These kinds of pre-built software frameworks can cut months off development and organizational alignment efforts and establish digital foundations for faster development, according to Emerson. The modality library also works to facilitate integration into execution systems to digitally transfer specification information into working recipes.
