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Decreased enzyme function will result depending on whether there are one or two copies of the MTHFR gene mutation present

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Importance of Aggregate Analysis Aggregates may: Alter pharmacokinetic behavior Increase immunogenicity risk Reduce therapeutic potency Impact formulation stability Analytical Challenges Aggregate characterization often requires: Orthogonal analytical methods SEC coupled with MS Native mass spectrometry Stability-indicating analytical workflows Using multiple complementary techniques improves confidence in impurity detection and biosimilar comparability

Nutrients 12:114