Emerson has collaborated with Roche to deliver a digital library of modalities for faster deployment and utilisation of DeltaV Process Knowledge Management (PKM) software, minimising the time it takes to develop a process specification through its lifecycle to full commercial scale.
Emerson
The DeltaV PKM Modality Library provides a set of software building blocks to help organisations quickly establish a modular approach to characterising process definitions. By further standardising process specification elements and relationships, life sciences innovators can more rapidly deliver lifesaving and life-improving treatments to patients in need.
Today it can take months to establish an organisation’s standards and then create the associated validatable building blocks using the PKM collaboration environment. Users must align on an ontology, equipment classes and capabilities, use of materials and formulations, quality testing plans, etc., before they can begin creating process specification recipes. All of this must also be aligned with the submission and licensing process and within the global supply chain.
Technology transfer is a major obstacle in delivering new medical breakthroughs to patients globally. This specialised library can allow companies to overcome this hurdle by streamlining and accelerating the move from research to commercial launch.
PKM software is designed to dramatically improve and shorten the technology transfer process. It replaces manual methods with a structured repository to define the process specification and a collaborative digital platform to manage changes as that specification evolves during the process development lifecycle.
The DeltaV PKM Modality Library provides a prebuilt, proven, customisable set of specification elements where the framework for the elements is already established for a given modality. This includes examples of underlying process steps, activities, key process parameters and critical quality attributes.
Prebuilt software frameworks cut months off development and organisational alignment efforts and establish digital foundations for faster future innovation. The modality library then facilitates seamless integration into execution systems to digitally transfer specification information into working recipes.
“Today’s life sciences innovators love PKM’s ability to shorten technology transfer but are continually searching for ways to improve alignment between process development and manufacturing recipe development,” said Nathan Pettus, president of Emerson’s process systems and solutions business. “The DeltaV PKM Modality Library enables a fully digital path to technology transfer, making the entire process faster, easier and more repeatable and reliable.”