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Critical Challenges and Solutions for Viral Vector Manufacturing – In-Process Analytics and Monitoring
In viral vector production, in-process analytics are essential for real-time monitoring and control of critical parameters to ensure consistent product quality, optimize process performance, and minimize batch failures. Examples of in-process testing include cell count and viability analysis, metabolite analysis, infectious titer determination, host cell protein analysis, vector genome analysis, and therapeutic protein analysis. However, challenges exist, such as the uncertainty of product quality during process establishment and the difficulty of obtaining immediate feedback without interrupting the manufacturing process or introducing contaminants.
A 100 percent fully closed viral vector manufacturing platform, with sealed and sterile chambers, closed media and reagent delivery systems, closed sampling and monitoring systems, closed harvest and purification systems, closed formulation and fill-finish systems, closed waste management systems, integrated control and automation systems, and single-use components, simplifies the challenges surrounding in-process analytics. Real-time data from integrated sensors and monitors enable immediate adjustments, reducing sampling times and the risk of contamination while improving process efficiency and maintaining product quality.