Searching for Purity
Examining the manufacturing process
with FXIa removal in mind
Separating FXI from immunoglobulin is a challenge
Immunoglobulin preparations are traditionally obtained by stepwise fractionation of plasma using ethanol precipitation.1 However, during this process, it is difficult to separate coagulation factor XI (FXI) from immunoglobulin G (IgG) because the isoelectric point (pI) of both is similar6:
One study showed that while coagulation factors FII, FVII, FIX, and FX are effectively removed through common fractionation processes, FXI remained at a residual ratio of approximately 15%–16%.6
Anion exchange chromatography, a commonly used purification step for immunoglobulin, is also ineffective at separating IgG from FXI because both IgG and FXI are positively charged molecules, so both proteins pass through the column together.6
Manufacturers have conducted studies to examine the purification process step-by-step to determine effective methods for reducing FXIa.
Finding the way to cleaner IVIG
Key process steps that have been shown as capable of removing or inactivating coagulation factors are12:
Innovations in manufacturing processes have proven effective at reducing FXIa to below detectable limits.6, 17
See Results of One StudyTake a closer look at IVIG-related TEEs
