Our QC Department performs in-process assays, handles raw materials testing and supports process development and customer-specific process validation. Both routine and customer-specific analytical assays are offered. The QC Department also performs routine environmental monitoring of the facility and utilities.
QC provides analytical support for the development of manufacturing bioreactor and purification activities. Typical assays include analysis of cell culture nutrients and metabolites as well as assays for product characterization, safety and purity. In addition, QC personnel assist in the development of analytical methods.
The development of analytical methods is a critical component in the development and manufacture of biopharmaceutical products. A wide range of techniques is required to characterize the product and to support studies to evaluate product stability, process and product consistency and repetitive equivalence studies following process changes.
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