Characterization of advanced therapies: leveraging advanced analytics to avoid FDA holds

Cell & Gene Therapy Insights 2022; 8(5), 745;

DOI: 10.18609/cgti.2022.112

Published: 10 July 2022
Dana Cipriano, Alexei Saveliev

  • Key assay types needed for successful characterization
  • CBM’s analytical strategy to address the need 
  • Orthogonal approach for early product characterization
  • Next generation sequencing for product characterization

Dana Cipriano has a 20+ year career in biotechnology with leadership roles focused on conceiving and designing processes and programs to drive sustainable growth and profitability. Before joining CBM, Dana was most recently Senior Director of Operations & Strategic Projects for WuXi Advanced Therapies where she directed operations for cell and gene therapy and biologics testing. At WuXi, she created the overall program strategy, drove tactical implementation plans, and monitored key milestones to drive delivery of organizational objectives. She developed a fully integrated program for the development of new corporate strategy centered on driving scalability in cell and gene therapy and biologics testing services. Dana has a Masters in Microbiology from Thomas Jefferson University and a Bachelor’s in Biology from Rutgers University and is PMP certified.

Alexei Saveliev has a 20+ year career in molecular biology with operational roles focused on practical applications of massively parallel sequencing in gene therapy and translational research. Before joining CBM, he was Senior Scientist, NGS Process Development at Azenta Life Sciences where he worked on the implementation of third-generation, long-read sequencing approaches for deep analysis of gene therapy vectors. He was also Associate Director of the newly created Nucleic Acid Technologies Core at the Gene Therapy Program, University of Pennsylvania where he developed comprehensive analytical infrastructure, implemented a novel bioinformatics pipeline for upstream vector production, managed a team of NGS scientists, and contributed to hundreds of individual NGS projects as well as several research papers. Alexei has a Masters in Genetics and a Certificate in Business Administration from The Wharton School.