Promotional graphic for a CGT Webinar Series by Pharmaron titled "Flexible Facility for Fast AAV Delivery." Features photos and names of four presenters: Vaughan Thomas PhD, Robert Olliver, Kieron McIntyre, and Richard Cooper. DNA strand and Pharmaron logo are in the background. Discover insights into bioanalytical development.

Flexible Facility for Fast AAV Delivery

Recorded: March 2023

This webinar will discuss how facility design & operation and advanced analytics, support the manufacturing of viral vectors with focus on speed and quality of drug substance to the clinic.

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Agenda

  1. Introduction
    • Considerations for successful GT manufacture
    • Differences between manufacturing GTs compared to other biologics > broad considerations
    • Design of effective development and manufacturing spaces with importance on a modern flexible facility
    • Analysing and maximising capacity of our space
    • Creating a facility which can manage scale up
    • Analytical considerations for GTs > small volumes, GMP compliance
  2. The Flexible Facility
    • Project throughput from development to GMP (with continuity of team)
    • Flexible product streams for multiple GT projects
    • Single footprint for Pilot Plant and GMP to increase speed to Clinic
    • Case study – increased speed to clinic
  3. Advanced Analytics
    • Complex approach to monitor GT critical quality attributes
    • Adapting traditional methodologies to address GT challenges
    • Advanced Analytics for QC: Making AUC GMP compliant
    • Platform approach to GT: AAV Multi-serotype methods
  4. Robust Utilities to maximise up time
    • Rotary USP
    • Ozone on water system distribution
    • N+1 Redudancy
    • Ultrasonic vibration analysis

Moderated by:

Derek Ellison, PhD – VP, Biologics Services Europe at Pharmaron Gene Therapy

Speakers

Key Opinion Leader: Vaughan Thomas, PhD – Bioprocess Consultant, Tillingbourne Consulting

Vaughan Thomas provides consultancy services to production operations on process alternatives, capacity analysis, and manufacturing options. Before setting up his company in 2010, Vaughan had been with SciTech Engineering for 6 years. He had previously held positions at Wellcome Biotech and ICI Pharmaceuticals, and as a Senior Engineer at Raytheon and Jacobs Engineering.  His career in biotechnology design spans 30 years, encompassing fermentation development, technical support to purification operations, facility & process design, and start-up consultancy. During the COVID-19 pandemic, he acted as a technical advisor to the UK Vaccines Taskforce.

Vaughan Thomas holds undergraduate and doctorate degrees in Biochemical Engineering from University College London and is a Fellow of the Institution of Chemical Engineers. He is a Visiting Professor at UCL where he is also Outreach Manager for the Future Targeted Healthcare Manufacturing Hub.

Rob Olliver – Director, Process Sciences at Pharmaron Gene Therapy

Rob leads cGMP Production at Pharmaron and is the responsible person for Production and Warehousing. Over his 13+ years at the site, Rob has lead numerous cross functional operational improvements projects throughout the manufacturing facilities and the site. Rob has 20+ years experience in clinical & commercial manufacturing and has been instrumental in securing successful MHRA inspections. Rob is also a qualified Prince2 Practitioner.

Kieron McIntyre – Associate Director, Analytical Sciences at Pharmaron Gene Therapy

Kieron is the subject matter expert and responsible for managing analytical method validation and technology transfer across for Pharmaron Gene Therapy.  In his role he leads cross functional teams and collaborates with strategic partners to drive technology transfer projects, from early state development through to registration with EMA, FDA and JNDA. With 13+ years experience within the pharmaceutical industry Kieron has a strong background in QC including acting as QC lead for successful MHRA inspections.

Richard Cooper – Associate Director, Project Engineering at Pharmaron Gene Therapy

Richard is a chartered Chemical and Biochemical Engineer with nearly 30 years experience in the pharmaceutical industry.  In this time, he has developed core competences in Process Engineering/Safety, Program and Project Management by designing and implementing strategic and business critical engineering solutions in small molecule development, bulk API and biologics manufacturing.  Currently Richard is the client lead and process subject matter expert for a new multi-million pound biologics site expansion project at Pharmaron’s Gene Therapy CDMO in Liverpool, UK.