Analyzing New Drug Modalities: An ISC 2024 Interview with Kelly Zhang

Kelly Zhang is a Senior Fellow and Director at Genentech. She leads analytical R&D teams on both drug substance and drug formulation. She has over 20 years of pharmaceutical industry experience at Genentech, Allergan and Pfizer. She has published over 80 peer-reviewed papers in the field of pharmaceutical analysis, covering synthetic molecules, biologic conjugates and nucleic acid based medicines. She is a member of the Permanent Scientific Committee of the International HPLC Conferences and the International Pharmaceutical and Biomedical Analysis Conference.

Kelly was interviewed at ISC 2024 by LCGC international and answered the following questions related to analyzing new drug modalities, such as mRNA, oligonucleotides, peptides, and cell and gene therapies.

• What specific analytical challenges do new drug modalities present for separation scientists?
• What role does chromatography play in the characterization of complex formulations used for drug delivery, such as lipid nanoparticles and polymer drug conjugates used for drug delivery?
• What are the most recent innovations using chromatography in biopharmaceutical analysis?
• What future trends do you see for chromatography in biopharmaceutical applications?