Viral vector production guide: part 3. Standardizing the manufacturing process

Cell & Gene Therapy Insights 2023; 9(2), 265;

DOI: 10.18609/cgti.2023.040

Published: 3 April 2023
FastFacts
James Cody


Watch the video or view the poster for insights into:  

  • Building with the end in mind: how to start with commercial process before starting small scale and how to include the principles of Quality by Design
  • Considerations for leveraging a platform approach to simplify manufacturing process
  • The effect of using adherent or suspension production on manufacturing scale and what situations may call for a specific production system
  • Utilizing phase-appropriate QC testing and the importance of product-specific release methods during all stages of production


James Cody is a Senior Manager of Business Development in the GMP services team at CRL-Rockville (formerly Vigene Biosciences). He received a PhD in cancer gene therapy from the University of Alabama at Birmingham, working primarily with oncolytic adenoviral vectors, and he completed postdoctoral training at the same institution, evaluating cancer treatment strategies based on oncolytic HSV. After his time at UAB, he then spent four years conducting research in fields including virology, cell biology, cancer, and parasitology. Dr Cody joined Vigene Biosciences in 2018, prior to its integration into Charles River in 2021.