AAV capture purification scaling from bench to clinical manufacturing

Cell & Gene Therapy Insights 2024; 10(7), 965;

DOI: 10.18609/cgti.2024.110

Published: 27 August
FastFacts
Kathleen Mihlbachler


Watch the video or view the poster to learn more about:

  • Understanding the sequential implementation of RoboColumns, MiniChrom, and OPUS pre-packed columns in gene therapy manufacturing for efficient resin screening, process optimization, and scalability. 
  • Recognizing the significant advantages of pre-packed columns, including reduced risk in manufacturing processes, cost savings, and enhanced facility efficiency by eliminating the need for column packing and qualification. 
  • Exploring the value of serotype specific and caustic stable affinity resins for the capture of AAV vectors.

Dr.-Ing. Kathleen Mihlbachler is a global technology leader in process chromatography, specializing in continuous operation. In her current position as Director of Process Engineering at Repligen, she is focused on the development and commercialization of innovative single use chromatography and TFF platform technology and their process applications. Prior to joining Repligen, Dr Mihlbachler was the principal architect of the YMC Twin platform by successfully leading the tech transfer of the ChromaCon’s technology to the process scale. Dr Mihlbachler worked for over 10 years in different Sr. Research positions at BMS, Eli Lilly, and Pfizer. She was involved in the development, scale-up, and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides, oligonucleotides, and proteins, including the implementation of innovative continuous processes. From 2011 to 2013, Dr Mihlbachler also taught undergraduate courses in chemical and biomedical engineering at New Jersey Institute of Technology.