For recombinantly produced biologics, the primary hurdle is mitigating residual HCP activity of lipases and esterases that threatens formulation stability. Current workflows often rely on capital-intensive proteomics or weeks-long incubation studies to assess surfactant degradation, creating significant analytical bottlenecks. These delays inflate the cost per sample and slow down critical decision- making. To optimize DSP development, the focus must shift from conventional, low-throughput methods to rapid, functional assessment.

Aminoverse transforms this landscape by targeting the catalytic nature of HCPs. By utilizing specialized fluorogenic substrates and kinetic analysis, our technology identifies and quantifies the activity of specific PS-degrading enzymes directly at formulation-relevant pH. This approach provides a rapid, highly specific functional readout that standard identification methods cannot offer, allowing for real- time enzyme class attribution that eliminates the need for redundant, slow-moving stability tests.

We recently enabled a high-throughput development program for a CDMO to optimize their post-DSP analytical workflow:

• Identification of active surfactant-degrading hydrolases (lipases / esterases)
• Through-put of 1,000+ samples/day with same-day turnaround
• Reduction of analytical costs by >20-fold with <$100/sample