In-Line Monitoring and Real-Time Release

Overview

This program is a collaboration between leading biopharmaceutical manufacturers and supply partners, working together to understand what it takes to adopt in-line monitoring and real-time release as described in BioPhorum Technology Roadmapping roadmap vision 1.0.

BioPhorum is working with industry, bringing together thought leaders and fostering rich and dynamic discussions that enable forward movement of the ILM/RTR vision. The groups are multi-disciplinary and provide a place to draw on one another’s experience, accelerating ILM/RTR as a whole in the industry.

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Subject matter experts (SMEs) from BioPhorum’s member companies have joined together to form a truly cross-functional team, focusing on the challenge of industry adoption of ILM/RTR, bringing diverse perspectives from across the industry. Most of the SMEs are involved in at least one of the other BioPhorum workstreams dedicated to the advancement of specific building blocks that will enable the adoption of ILM/RTR. Each building block is valuable in its own right and will represent significant change. Together, they will allow biopharmaceutical manufacturers to reach the ulitmate goal of automated process control and automatic release

The priority for the program is to support the business requirements for adoption, and the team has now developed an operational vision. Taking a technology-agnostic approach, the vision articulates the beginning, middle and aspirational future states for adoption and a high-level sequence for implementation of ILM/RTR. This is important as it starts to describe how a factory of the future will operate and how organizations might stage their investment to get there from their current state.

Subject matter experts (SMEs) from BioPhorum’s member companies have joined together to form a truly cross-functional team, focusing on the challenge of industry adoption of ILM/RTR, bringing diverse perspectives from across the industry. Most of the SMEs are involved in at least one of the other BioPhorum workstreams dedicated to the advancement of specific building blocks that will enable the adoption of ILM/RTR. Each building block is valuable in its own right and will represent significant change. Together, they will allow biopharmaceutical manufacturers to reach the ulitmate goal of automated process control and automatic release
biophorum post images baselines 340

The priority for the program is to support the business requirements for adoption, and the team has now developed an operational vision. Taking a technology-agnostic approach, the vision articulates the beginning, middle and aspirational future states for adoption and a high-level sequence for implementation of ILM/RTR. This is important as it starts to describe how a factory of the future will operate and how organizations might stage their investment to get there from their current state.

biophorum post images baselines 340
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This operational vision includes process technology, operational systems, facility design and construction innovations that will increase capacity and enable efficient, sustainable processes, all from a patient-first perspective. It involves advanced process controls (APC), predictive modeling and ILM/RTRT to provide continuous quality assurance, a high level of control over variability, and automated release of product.

Resources

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Operational vision: Adoption of in-line monitoring and real-time release

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In-line monitoring / real-time release testing in biopharmaceutical processes - prioritization and cost benefit analysis

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BioPhorum Technology Roadmapping: Inline monitoring and real time release

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BioPhorum TRMx insights

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Biomanufacturing technology roadmap: 6. In-line monitoring and real time release

To register your interest in the ILM operational vision please register your interest using the form below :

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