Fierce Pharma Life Sciences Presents: Key Challenges and Opportunities in the Cell Culture Process Scale Up Webinar (Virtual)
Cell therapy products have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. However, establishing a scalable manufacturing technology that can reliably reproduce the yield and quality of derived products generated from small-scale R&D methods at larger scales sufficient for commercial manufacturing can pose many challenges.
In this webinar we discuss what these key challenges are, how to approach these challenges and some opportunities available to better the process including:
Understanding the key challenges:
○ Geometrical differences
○ Different hydrodynamics
○ Various scale-dependent factors
Comparison of traditional and data-driven scale up strategy
Meeting the challenges and creating opportunities
Seungsun Lee Lead Scientist, Team Leader MSAT USP team, Samsung Biologics
After obtaining a master’s degree in Cell Engineering, he continued on to establish a career in diverse scientific areas such as in cell culture process development, tech transfer, validation, and cGMP. Before joining Samsung, he participated in numerous production process development using various animal cells including CHO cells for antibody and fusion protein production. He also had experience with bacteria, yeast fermentation and virus production. After years of working at such donor sites, he finally went on to join Samsung Biologics in 2016, leading cell culture tech transfer projects ranging from orphan drugs to blockbuster and biosimilars.
Furthermore, he took part in the setup of the N-1 perfusion process in Plant 3, which was carried out very successfully, resulting in cell productions with high concentrations.