Navigating variability and scalability challenges in AAV production

Cell & Gene Therapy Insights 2024; 10(7), 1065

DOI: 10.18609/cgti.2024.121

Published: 5 September
FastFacts
Rafal Garus


Watch the video or read the poster for insights into:

  • when a comparability study is needed for your gene therapy program;
  • the main challenges experienced during comparability studies for gene therapy programs;
  • how to set up a comparability study based on the risk assessment and available process knowledge; and
  • key process parameter adaptations needed for scale-up to 2,000 L single-use bioreactor.

Since 2023, Rafal Garus MSc MBA has been the Director of Viralgen’s Manufacturing Science and Technology (MSAT) department. Previously, he was the Head of MSAT Analytical Methods at Bayer, a role he held for 6 years before joining Viralgen. Prior to his experience at Bayer, Rafal worked for multiple biotechnology companies, including Solvias and Novartis. With a span of experience of over 20 years, Rafal brings his expertise in development and commercial support of biotechnology products to ensure the success of Viralgen’s MSAT operations.