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