Analytical methods for IVIG
Assay Method | Utility/Intended Use |
Thrombin generation assay (TGA) | Quantitative Test for Process-Related Impurities: Factor XIa and “Factor XIa-like” activity |
Factor XIa chromogenic assay | Quantitative detection of FXIa present in the sample |
NAPTT | Detection of active contaminant clotting Factors with thrombogenic potential |
Protein G HPLC | Identification/quantitation test for purity |
Size exclusion HPLC (SE-HPLC) | Identity/Molecular Size Distribution |
SDS-PAGE, non-reduced | Identification/Quantitative Test for Purity |
SDS-PAGE, reduced | Identification/Quantitative Test for Purity |
Total protein, Bradford assay | Protein concentration |
Na-Caprylate | Quantitative Test for Process-Related Impurity: Sodium Caprylate |
Glycine | Quantitative Test for Excipient: Glycine |
PKA | Quantitative Test for Process-Related Impurity: PKA |
Plasmin | Quantitative Test for Process-Related Impurity: Plasmin |
Plasminogen | Quantitative Test for Process-Related Impurity: Plasminogen |
Anti-complement activity | Quantitative Test for Process-Related Impurities: Anti-complement antibodies |
Hemagglutination for Anti-A and Anti-B | Quantify levels of anti-A and anti-B antibodies |
Anti-D antibodies | Quantify levels of anti-D (Rh factor) antibodies |
Fc Function Test | Ensuring that Fc-mediated functions are maintained |
Fibrinogen (ELISA) | Quantitative measurement of Fibrinogen |
pH | Ensure Correct pH of Drug Product |
Osmolality | Ensure Correct Osmolality of Drug Product |
To Learn More
Contact us using the form on the right or call us at +1 (802) 878-1777 to learn more about how we can assist you with characterizing your IVIG drug product.