The Quality Control Laboratory is responsible for continuously monitoring critical parameters in the environment of the target product, starting from process development through production and purification stages. The laboratory is equipped with various systems and analytical techniques to ensure consistent product quality and process efficiency.
In-Process Control Sensors: Critical parameters such as pH, pO2, and temperature are continuously monitored in bioreactors to maintain optimal culture conditions. Additionally, pressure sensors enable real-time monitoring and control of the filtration process during tangential flow filtration (TFF).
Vi-CELL XR Automated Cell Analyzer: This cell analyzer can count up to 15x10⁶ cells/mL with a sample volume of 170 µL. It is used for the rapid and precise measurement of cell density, ensuring accurate cell culture monitoring.
SFR Vario Sensor System: This system is compatible with the Infors shaking incubator and allows for non-invasive monitoring of critical parameters such as pH and pO2 in the culture environment. This feature supports the maintenance of optimal conditions for cell culture growth.
Mycoplasma and DNA Analysis: Using the QIAGEN Rotor-Gene Q quantitative PCR system, kit-based mycoplasma analysis and other DNA analyses are performed. This system enables the rapid and reliable detection of genetic contamination.
Endotoxin Analysis: Endotoxin levels are measured using a kit-based method with a Shimadzu spectrophotometer. This analysis is crucial for identifying endotoxin contamination in biological products, ensuring their safety and compliance with quality standards.
