Holistic Analytical Characterization and Risk Assessment of Residual Host Cell Protein Impurities in an Active Pharmaceutical Ingredient (API) Synthesized by Biocatalysts
Fengqiang Wang1, 2*, Xuanwen Li3, Michael Swanson4, Erik Guetschow1, Matthew Winston5, Joseph P. Smith3, Erik Hoyt1, Zhijian Liu5, Douglas Richardson3, Xiaodong Bu1, Vibha Jawa4, Narayan Variankaval1*
1Small Molecular Analytical Research & Development, Rahway, NJ
2Biologics Analytical Research & Development, Kenilworth, NJ
3Analytical Enabling Technologies, Analytical Research & Development, Kenilworth, NJ
4Pharmacokinetics, Pharmacodynamics & Drug Metabolism (PPDM), West Point, PA
5Small Molecular Process Research & Development, Rahway, NJ
Merck & Co. Inc, 2000 Galloping Hill Rd., Kenilworth, NJ 07033
*To whom correspondence should be addressed to:
Email: Fengqiang.wang@merck.com or Narayan.variankaval@merck.com