8:30am | Coffee & Networking

9:15 am Chair’s Opening Remarks

Ensuring Viral Vector Potency, Purity, & Stability

9:30 am 50 years of Quantifying Adenovirus Particles

Synopsis

  • The simplicity of the Maizel extinction co-efficient to support viral vector vaccine analytical development
  • Human Ad5 Reference Material vs Recombinant virus with genome packaging variants
  • What is the best path forward for optimizing vaccine analytics?

10:00 am Analytical Characterisation of Adenovirus-based Vaccines (ChAdOx & Ad5)

  • Shaleem Jacob Research Fellow, Novel Vaccine Manufacturing Characterisation, Department of Biochemical Engineering, UCL

Synopsis

• Product quality understanding is a critical part of vaccine manufacturing and regulation
• Use of mass spectrometry to identify key viral proteins that are involved in virus maturation and infectivity
• Analysis of two viral vector-based vaccines, Chimpanzee adenovirus (ChAdOx) and Human Adenovirus Type 5 (Ad5), both of which are used commercially and observed differences in key proteins that could
potentially be used as critical quality attributes (CQA).
• Proposal of this technique to be implemented for commercial vaccine production

10:30 am Hassle-free AAV characterization on Stunner

Synopsis

•Get quick capsid titer, empty/full ratio and aggregation data from 2 uL of sample with Stunner

•Learn how Stunner combines UV/Vis, DLS and SLS to analyze your AAV sample

•See how Stunner compares to ddPCR, ELISA and AUC

10:45am | Morning break

11:30 am Harmonizing Molecular Assays for Vector Tittering

  • Jordan Smith Research Associate II, Molecular Biology, AskBio

Synopsis

• Challenges in vector tittering assays: standards, platforms, programs, and applications
• Harmonization approaches: platform assay development and assay optimization strategies
• Raising the bar for analytical methods

12:00 pm Panel Discussion: Analytics Going Viral – Tools to meet the needs of viral vector analysis

  • Maria Belousova Senior Scientist, Analytical Development Molecular Biology Group Leader, AskBio
  • Shaleem Jacob Research Fellow, Novel Vaccine Manufacturing Characterisation, Department of Biochemical Engineering, UCL

Synopsis

• This panel will discuss the current state of the art, challenges, and potential solutions around the
analysis of viral vectors

12:30pm | Lunch

2:00 pm Analytical Tools for Product Release Testing of Therapeutic AAV

  • Gary Li Director, QC Analytics, Capsida

Synopsis

• Overcoming challenges associated with AAV quantitation and identification
• Assessing the analytical steps in viral vector production and identification of better and more robust methods

2:30 pm Panel Discussion: Future Direction of Analytical Capabilities for Better Vaccines

  • Lawrence Thompson Senior Principal Scientist, Analytical R&D , Pfizer
  • Ravi Ganapathy Head, Vaccine Process Development , International Vaccine Institute
  • Thomas Cleveland Physicist, National Institute of Standards and Technology, Biomolecular Measurement Division

Synopsis

  • Are modified protein-based therapeutic assays enough for genetic vaccines, or are we in dire need of the development newer, more modern analytical tools?
  • What are the current gaps in analytical tools to ensure future success of genetic vaccines for infectious diseases and oncology indications?
  • Where will future innovation come from and how must regulation change to support newer techniques?

3:00pm | End of Day Two