The Challenge: The “Black Box” in the Bioreactor
Traditionally, bioprocess monitoring relies on the aseptic withdrawal of samples, the analysis of which often takes several hours in the QC Laboratory. During this time-lag between sampling and result, the bioreactor is essentially a “Black Box.” Critical process deviations such as nutrient limitations, metabolite accumulation, or a decrease in cell viability are only detected belatedly. This delayed response leads to suboptimal growth conditions, fluctuations in Product Quality (CQA), and a reduced Batch Yield.
The Solution: Continuous Process Guidance through PAT Systems
Real-Time Insights Instead of Retrospective Analysis
Our Inline PAT Systems are specifically designed for the non-invasive and automated monitoring of bioreactors and Downstream Processing (DSP). They enable the continuous acquisition of biorelevant parameters directly within the process.
Key Features and Technological Advantages:
- Multi-Sensory Integration: Utilizing a technology platform that combines various measurement principles to cover the entire spectrum of CQAs. This includes:
- UV/Vis Spectroscopy (Fluorescence/Absorption) for determining Protein Concentration and Cell Density.
- Immersion Probes or Flow-Through Cells with optical windows that ensure contamination-free monitoring directly in the medium.
- Multi-Component Analysis in Real-Time: Simultaneous and continuous monitoring of critical substances and cell parameters with a single probe or an integrated measuring section.
- Process Modeling and Prediction: The captured real-time data feeds Multivariate Data Analysis (MVDA) models that enable precise predictions about the optimal harvest time or necessary feeding strategies.
- Robust Measurement Technology: Specifically developed for the harsh process conditions in the bioreactor (high cell density, turbidity, sterilization cycles such as Sterilization-In-Place, SIP).
- GMP and Regulatory Compliance: The systems are validatable and provide the necessary data integrity for regulatory submissions and validation documentation.
Your Added Value for Bioproduction
With our Inline PAT solution, you close the information gap in the bioreactor and establish data-driven process control.
Your Advantages at a Glance:
- Stable CQA Profiles: Reduction of process variability and assurance of consistently high product quality.
- Maximized Yield: Optimization of feeding rates and harvest time based on real-time data.
- Faster Time-to-Market: Acceleration of process development and scale-up through deeper process knowledge.
Conclusion: Create transparency in your cell culture – for a more efficient, robust, and regulatory-compliant manufacturing of your biologics.