Biogen Inc.: Comparison of Protein Concentration Determination of a mAb Drug Substance Using Variable Pathlength Spectroscopy and UV-VIS Spectroscopy

In recent years a new technology known as “Variable Path Length Spectroscopy” (e.g. SoloVPE from C Technologies Inc.) has been developed for the determination of protein concentration in biologics such as monoclonal antibody drug substances (mAb DS). The advantage of this new technique is its increased dynamic range and resulting minimized sample handling, which leads to increased throughput and also mitigates the risk of dilution errors compared to conventional UV. In this case study for a mAb in latestage clinical development, it was desirable to change from a traditional UV method to SoloVPE for DS release, and it was shown that the protein concentration was significantly impacted by the choice of method (SoloVPE or SoloVPE LS (Corrected for Light Scattering)) compared to the historical conventional UV method. The decision to implement SoloVPE for DS release was considered using a risk-based approach.