Recorded: October 2022

This webinar will discuss the move towards high throughput systems within process and analytical development to drastically reduce CMC development timelines, maximize productivity, and drive results.

Key Messages on High-Throughput Robotics: 

  • The importance of small scale HTP USP and DSP systems, to assess a product’s fit to a platform process with high speed and accuracy
  • The use of Ambr15/250 bioreactor systems to reduce cost, space and resource compared to a laboratory scale run
  • The use of a HTP downstream robotics platform to allow rapid screening of multiple parameters for a highly optimized purification process
  • The use of fully integrated HTP analytics which are essential to meet the outputs of a HTP process development approach
  • The use of a targeted HTP approach to development to drastically reduce CMC development timelines, maximise productivity and drive results

Agenda: 

  • Introduction to HTP systems
    • What are HTP systems, what is HTPD and what are HTP analytics?
    • Current challenges and bottlenecks of low throughput systems
    • Benefits of HTP systems
    • Specifics for use in Gene Therapy
  • Pharmaron’s HTP capabilities
    • Introduction to Pharmaron’s development pathway
    • Use of HTP systems to optimise upstream development
    • Use of HTP systems to optimise cell line development
    • Use of HTP systems to optimise downstream development
    • Use of HTP systems to reduce analytical bottlenecks
    • Introduction of a tiered testing approach at Pharmaron
  • High-throughput, automated analysis of viral vector titre and process-related impurities with Gyrolab®
    • Collaborative work between Gyros and Pharmaron to develop a HTP titre method for AAV analysis
    • Support by Pharmaron for beta testing the AAVX and AAV9 titre kits