Virus inactivation is an essential step in the purification of biologics (mAbs, viral vectors, blood product, etc.) derived from the cell expression system, plasma fractionation, etc. Conventionally, S/D (solvent/detergent) is widely applied to inactive enveloped virus, among which Triton X-100 is the most used detergent. However, due to its environmental risk, Triton X-100 has been banned in Europe. The industry has been searching for suitable replacements for Triton X-100. This study will validate the virus inactivation efficiency of hydroxypropyl beta-cyclodextrin (HPBCD) applied in the harvested cell culture fluid (HCCF) or protein A eluate. The compatibility of HPBCD in the subsequent downstream processes will also be investigated.

HPBCD is an effective virus-inactivation agent that ensures the viral safety of biologics. It is compatible with downstream processes, maintaining product stability and purity. Given that HPBCD has been proven safe for parenteral administration, as evidenced by its use in many approved drugs, it can potentially remain in the final drug formulation. Additionally, HPBCD can serve as a stabilizer, protecting biologics from the stresses encountered during various manufacturing process steps.