Process Analytical Technology (PAT) systems are transformative tools in modern bioprocessing that enable real-time monitoring, control, and optimization of critical process parameters and product attributes. Developed to support the Quality by Design (QbD) framework encouraged by regulatory agencies such as the FDA, EMA, and ICH, PAT systems are essential for enhancing product consistency, process understanding, and regulatory compliance in biopharmaceutical manufacturing, cell therapy production, and industrial biotechnology.
PAT systems integrate a suite of sensors, analytical instruments, and software tools to monitor variables such as pH, dissolved oxygen (DO), glucose, lactate, viable cell density, biomass, osmolality, and metabolite concentrations during bioprocess runs. These systems often include Raman spectroscopy, near-infrared (NIR) sensors, dielectric spectroscopy, and inline chemical analyzers, which collect real-time data on the state of the culture and the quality of the final product. By capturing this information in real time, PAT systems empower operators to make immediate, data-driven decisions or allow automated control systems to adjust conditions proactively—minimizing process drift and reducing the need for offline sampling.
In upstream processes, PAT systems help optimize media feeds, oxygenation, agitation, and temperature, ensuring optimal conditions for cell growth and protein expression. In downstream purification, PAT tools monitor chromatography breakthrough points, buffer composition, and filtration performance, ensuring product quality and maximizing efficiency.
PAT implementation supports process scale-up, tech transfer, and long-term GMP manufacturing, aligning with digitalization and Industry 4.0 initiatives. These systems improve batch consistency, reduce production variability, and enhance overall process robustness—while also streamlining documentation for regulatory submissions.
At Wasteless Bio, we offer surplus and refurbished PAT system components, including Raman probes, integrated controllers, software platforms, and inline analyzers. Each listing includes specifications such as measurement range, data integration options, system compatibility, and regulatory certifications. By sourcing PAT systems through Wasteless Bio, labs can build cost-effective, real-time bioprocess monitoring solutions while contributing to sustainable, data-driven manufacturing practices.
Process Analytical Technology (PAT) systems are transformative tools in modern bioprocessing that enable real-time monitoring, control, and optimization of critical process parameters and product attributes. Developed to support the Quality by Design (QbD) framework encouraged by regulatory agencies...