Project Overview

Our client is constructing a new plant, Lebanon Advanced Therapies (LP2), In Lebanon, IN, for the manufacture and distribution of novel modality pharmaceutical products. The first phase of the plant, dedicated to manufacture of gene therapies, is expected to be operational in 2026.

Creation of reusable templates to define the data collection from the following UNS specifications (defined as MQTT payload formats, topic structures, and interaction diagrams) on the HighByte or Kepware Intelligence Hub Integration Platform.

Support the population of the UNS HighByte templates, adapt and modify as new process equipment is commissioned. Create the final HighByte configuration.

Definition and delivery of MS SQL database schema for permanent archival of UNS events. Implementation of HighByte Intelligence Hub Pipelines for data collection from the UNS and population of the MS SQL database(s), documentation and validation. **

Qualification of the HighByte Intelligence Platform, MS SQL Database, the Edge of Network Device and any other platform components are Out of Scope.

These will be applied to process automation systems in the Drug Substance area, the Drug Product area, and Utilities for commercial-of-the-shelf (COTS) systems. Implementation of the UNS specifications is out of scope within site custom developed automation solutions as they are not using HighByte,

**For custom developed automation systems, storage of these data from UNS are in scope similar to COTS systems, as they will be using the same UNS Specifications.

Deliverables

This Statement of Work describes the deliverables and support required to develop and deliver the LP2 Automation Integration System as well as support Automation Engineering in asset delivery to turn over fully validated systems to operations.