How It Works Webinar
Available On Demand!
The biopharmaceutical industry is undergoing a significant transformation in how quality is managed, shifting from traditional end-product testing toward a model of continuous process assurance. This evolution is driven by the paradigm shift to Real-Time Release Testing (RTRT), where regulatory and economic incentives favor proactive monitoring over retrospective "Quality by Inspection." Central to this transition is a clear understanding of the Process Analytical Technology (PAT) framework, which aligns Critical Process Parameters and Critical Quality Attributes within a strict GMP-compliant structure.
To achieve this, manufacturers must overcome traditional analytical bottlenecks such as manual labor, contamination risks, and the lengthy data gaps associated with off-line sampling. Modern in-situ sensors, such as Incyte for viable cell density and GlucoSense for glucose monitoring, provide real-time solutions to these hurdles. Furthermore, the adoption of Smart Sensor Intelligence, specifically Arc Technology, allows for laboratory-based calibration and direct integration into PLC or SCADA architectures without the need for external transmitters.
This digitalization ensures absolute data integrity and compliance with CFR 21 Part 11 through automated documentation. Ultimately, implementing these smart systems during early process development creates "Golden Batch" profiles that streamline technology transfer and significantly accelerate the scale-up process.
As an attendee, you will learn more about:
- Understand the regulatory and economic drivers moving the industry from traditional "Quality by Inspection" (end-product testing) to "Real-Time Release Testing"
- Gain clarity on the relationship between CPPs (Critical Process Parameters), CQAs (Critical Quality Attributes), and KPIs (Key Performance Indicators) within a GMP-compliant framework.
- Identify common hurdles in off-line sampling, such as manual labor, 24-hour data gaps, and contamination risks, and how in-situ sensors solve them.
- Explore the benefits of Arc Technology, including laboratory-based calibration, event-driven maintenance, and direct integration into PLC/SCADA architectures without external transmitters.
