Senior BioPharma Research Manager Roquette Asia Pacific Pte Ltd Singapore, Singapore
This case study presents hydroxypropyl beta-cyclodextrin (HPBCD), a compendial excipient used in approved parenteral formulations, as a safe and effective alternative to Triton X-100 for virus inactivation in bioprocessing. Triton X-100 has been banned in the EU due to environmental concerns. Viral clearance studies show HPBCD effectively inactivates two model enveloped viruses spiked in harvested cell culture fluid (HCCF) of a mAb, achieving over 4.0 log₁₀ reduction within 30 minutes at 15% concentration. A combination of 5% HPBCD and 0.3% tri-n-butyl phosphate (TNBP) achieved complete viral inactivation in ≤ 5 minutes. Importantly, HPBCD does not affect product stability and purification efficiency. The removal efficiency of impurities, including host cell proteins, host cell DNA, and leaked protein, remains consistent, regardless of whether HPBCD is added in the HCCF. Additionally, HPBCD is easier to handle than other detergents and is readily removed during downstream processing, supporting its use in large-scale biopharmaceutical manufacturing.
Learning Objectives:
Upon completion, participant will be able to understand why Hydroxypropyl-Beta-Cyclodextrin as a safe and effective viral inactivation agent in bioprocessing
Upon completion, participant will be able to know how to incorporate Hydroxypropyl Beta-Cyclodextrin in bioprocessing for viral inactivation.
Upon completion, participant will be able to explore how Hydroxypropyl Beta-Cyclodextrin integrates into downstream processes without affecting product stability and purification efficiency, as well as its quantitation methods
