The BioPhorum Operations Group (BPOG) established a digital plant maturity model (DPMM) for biopharmaceutical manufacturing to define stages of factory evolution “from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future.” The model gives organizations a common tool for industry comparison and measurement of progress. It also provides a platform to facilitate collaboration within the life sciences industry and its technology providers. The aspirational target state for organizations using the BPOG DPMM is the “Adaptive Plant,” which is characterized by:
- Full end-to-end value-chain integration from suppliers to patients.
- Modular, mobile and collaborative Manufacturing Environment.
- Advanced production technologies used as standard.
- “Plug-n-play everything” from an instrument to a production scale or a contract manufacturing organization (CMO).
- Zero system down-time (including upgrades) – continuous evolution.
- In-line, real-time, continuous, closed loop, process verification and control with automated real-time quality release.
- Self-aware, continuously adaptive, “Autonomous” plant; exception conditions handled by remote experts.
- Advanced simulation used across value chain for modeling, testing and improving manufacturing and supporting business processes.
- Trusted information insights are freely and securely available.
- Pervasive use of adaptive analytics and Self / Machine learning across value chain.
Achieving a level of digital plant maturity commensurate with the “Adaptive Plant” requires a disciplined approach built on a technology foundation that allows for continuous evolution. Modern manufacturing facilities are beginning to incorporate an enterprise Product & Knowledge Management (PKM) solution, a Real-Time Modeling System (RTMS), and an Automation Integration Layer (AIL) to facilitate rapid product introduction, continuous optimization, and streamlined data acquisition and sharing.
The Fluxa PKM software is a web-based application that manages product and process specifications throughout the drug development lifecycle. Designed to facilitate collaboration, it enables global sites, functions, contract development organizations (CDOs), CMOs, and contract development and manufacturing organizations (CDMOs), to work together to scale recipes and execute technology transfers.
The Plantweb Optics Platform securely and efficiently connect and collects global operational data from manufacturing, process control, and IT systems without disruption, contextualizes it, and transforms it into actionable information, which is presented to every decision-maker on any device, anytime, at any location.
The Real-Time Modeling System software enables you to visualize the facility constraints, accommodate variability, maximize production, and understand the implications of any change in the manufacturing process.
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