The manufacture of biological-based medical treatments, such as cell and gene therapies or other biotherapeutics, carries the added risk of biological component impurities such as host cell proteins (HCPs). These HCPs can elicit adverse reactions in patients using the therapies. Given the high degree of complexity inherent in biological systems, being able to identify and quantify potentially unforeseen impurities can pose a challenge. Routine analytical techniques including the use of enzyme linked immunosorbent assays and Western blots can lack the key combination of features required for a quality control method to detect HCPs.
Download this whitepaper to discover approaches for the detection and quantification of HCPs that:
Streamline the process of impurity monitoring
Have broad sample applicability through mass spectrometry
Consider patient safety, product stability and purity
