Detection is routine. Isolation is the bottleneck.
Every biologic has eight or more modification sites — fragmentation, oxidation, deamidation, aggregation. Each one requires analytical and preparative separations before it can be structurally and functionally identified.
Detection on a gel takes minutes. Isolating a single variant for downstream testing takes weeks, sometimes months. One biopharma team spent four months developing a method to collect a single fragment — delaying a Phase III program.
The problem isn't detection. It's that no tool today can separate protein variants and collect them.
