In case of biologic drug substances produced by bioprocessing, occurrence of post-translational modification (PTM) or variants is common. Though the PTM forms exhibit a certain degree of structural heterogeneity, these can influence the structure and stability of proteins along with impacting its interaction. Though determination of PTMs is essential, it can be challenging as it requires a complex array of detailed analytics to confirm identity of protein, along with ensuring a consistent manufacturing process. To add to it, any incorrect modification may also result in a potentially harmful immune response.
At VIMTA, we offer post-translational modification and bioanalytical studies for large molecules through CE, HPLC and MS.