Why Skyland PIMS was Selected – Novavax

Headquartered in Gaithersburg, Maryland, Novavax is a late-stage biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s vaccine candidates are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis.

Operational Needs
Novavax has more than a decade of experience contending with some of the world’s most devastating diseases, including seasonal influenza, RSV, Ebola, MERS, and SARS. It is preparing to enter phase III clinical trials with NVX-CoV2373, a leading COVID-19 vaccine candidate. As part of the US government’s Warp Speed initiative, large scale manufacturing capacity is already being established for NVX-CoV2373 leveraging a global network of CMOs and partnerships.

Driven by its COVID-19 vaccine development and manufacturing data management complexities, Novavax wanted to harden its data infrastructure, discontinue wide scale use of Excel for batch/process/product data management, and accelerate data sharing among a large external network.

Evaluation Process
With accelerated production timelines a key focal point, selecting a system that would meet these timing requirements was a key factor. Staff involved in selecting a process information management system had extensive knowledge of the available solutions, including Discoverant, Statistica, and ProcessPad. Given these solutions involve lengthy deployment time, require added resources/overhead to manage, and have limited scalability, Novavax quickly identified PIMS as the right solution for their needs

Why Skyland PIMS?
The following were reported as top value props:
° Deployment Speed – Deployed in less than a week, PIMS™ enabled Novavax to fast track their COVID-19 data infrastructure ahead of scaling up global manufacturing operations
° CMO Collaboration – PIMS enables Novavax to monitor its supply chain and gain real time operational oversight of multiple CMO manufacturing sites worldwide
° Completeness – PIMS provides batch data and specifications and control limits management, analytics and integration capabilities with CMO historians

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