Manufacturing & Analytical Characterization

Rapid Fires: Shaping Biologics: From Molecules to Manufacturing Excellence

Rapid Fire Moderator(s)

• 

  Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)

  Sr. CMC Consultant
  CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
  Marina del Rey, California

Presentations:

• 3:00 PM - 3:15 PM CT

  Avoiding Adducts: Improving Oligonucleotide MS Data Through Ion Source Optimization
  

  Rapid Fire Speaker: Brian Domanski – Shimadzu Scientific Instruments, Inc.
• 3:15 PM - 3:30 PM CT

  ADA-SCID Manufacturing and Outcomes: Predictive Analytics Case Study
  

  Rapid Fire Speaker: Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers) – CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
• 3:30 PM - 3:45 PM CT

  Strategy for Bridging Methods for an Accelerated Late-Stage mAb
  

  Rapid Fire Speaker: Mania Dorrani, PhD (she/her/hers) – Merck & Co., Inc.
• 3:45 PM - 4:00 PM CT

  Molecular Modeling Assisted Critical Quality Attribute Assessment
  

  Rapid Fire Speaker: Zoey Zheng, PhD (she/her/hers) – Amgen