Associate Scientist Merck Research Laboratories Kenilworth, New Jersey
Host organisms used to manufacture biologics also produce process-related impurities, such as host cell proteins (HCPs) and DNA, which need to be monitored and reduced during downstream processing because of their potential to impact drug safety and efficacy. Additionally, problematic HCPs, such as lipases, can degrade polysorbates and other excipients used to improve drug stability. Polishing chromatography can clear these impurities but may reduce product recovery due to inadequate resin selectivity; therefore, novel filtration and column purification modalities for HCP and DNA removal are needed to address these challenges. Additionally, efficient HCP and DNA removal decreases the impurity burden on traditional downstream trains. This work evaluated the DNA, HCP, and lipase clearance capabilities of a novel peptide-based resin and a filter for harvest cell culture fluid (HCCF) and affinity chromatography products containing monoclonal antibodies (mAbs).
Learning Objectives:
understand current host-cell protein and DNA clearance challenges in biopharmaceutical development
assess the clearance capabilities of two novel modalities for impurity clearance
recognize the most optimal operating parameters for these modalities