AAV capture purification scaling from bench to clinical manufacturing

Watch the video or view the poster to: view case study data outlining the successful scale-up of an ion exchange chromatographic process to the KRMTM Chromatography system platform; see how gentle fluid management, low hold-up volume, and accurate pump performance can lead to higher recovery and consistency in the scale-up process; learn how to scale up the AAV capture step from the benchtop to GMP manufacturing while maintaining quality attributes such as purity, and improved process recovery; understand why process robustness and reproducibility are key for high productivity and cost-effective viral vector manufacturing at scale.

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.

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