Commercial Manufacturing

Implementing an unexpected downstream process change? Comparing HCP profile of the Drug Substance produced at two independent manufacturing sites? Changes in your purification process can lead to changes in the HCP profile of the upstream harvest and final drug substance. Cygnus’ AAE-MS orthogonal method is uniquely positioned to fully characterize process HCPs and ensure that your selected HCP assay can still be used as a product lot release method. AAE-MS provides direct actionable insights into these potential changes by identifying individual HCPs and confirming that the HCP ELISA previously validated remains a suitable method to detect and quantify these HCP. This information is especially important to assess the presence of problematic process-specific HCPs that could diminish product stability, drug efficacy, and even patient safety. A better understanding of how process changes impact the HCP profile is paramount to minimize impacts to product availability, quality and safety. 

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