Conference Day Two

Thursday 31st August 2023

8:30 am
Morning Coffee

9:20 am
Chair’s Opening Remarks

Marrying Your Analytical Development with CMC to Achieve Rapid Scale-Up

9:30 am Selecting the Right Partners for Outsourcing

  • Sara Häggblad Head of Chemical Manufacturing and Control, Lokon Pharma AB


  • What are the criteria of your viral vector CDMOs to support your clinical and commercial manufacturing? On vs. off vs. near-shoring?
  • Explanation of GMP facility requirements for viral vector production to help you when considering your new partner for outsourcing
  • Overcoming capacity and availability limitations for speed-to-patient

10:00 am Quantitative In Vitro Potency Assay for Viral Vectors

  • Roland Pach Global Expert Cell & Gene Therapy Analytics CMC, Roche


  • Comparing the different types of potency assays and how many you should use to assist you in accurately and cost-effectively determining the potency of your product
  • Challenges related to the development of in vitro potency assays and how to mitigate these for quicker development
  • Defining your measurements to enable confident product release and speed-to-market

10:45 am
Morning Coffee & Networking

Marrying Your Analytical Development with CMC to Achieve Rapid Scale-Up

11:15 am SEC-MALS Applications in Process Development


  • Advancements in the analytical development of characterisation to speed up your process and enhance scalabilty
  • Explanation of the downstream analytics surrounding purification to help your ensure high purity of the final product
  • How thorough characterisation and purification analytics can assisit in the development of a scalable product

11:45 am Analytical Characterisation Tools for Robust Assessment of AAV Purity


  • Developing a AEX HPLC method to determine the full:empty ratio of AAV capsids to assist in process development Using this data from the AEX HPLCS method to assist in the characterisation of our product
  • Demonstration of mass photometry as an orthogonal high throughput method for empty: full assessment

12:15 pm
Networking Lunch Break

1:15 pm Roundtable Discussion: How to Integrate Technologies to Improve Your Viral Vector Quality & CMC


  • Discussion based session design to promote discussion around integration 
  • Focus on cross-functional cooperation to ensure that all processes are integrated with early design 
  • Encouragement of increased productivity and decreased process time and hold-up volume by process automationKeep the title but please can we add these bullet points: 

2:00 pm Critical Quality Attributes, Characterisation & Platform Controls for Viral Vectored Vaccines


  • Defining the CQAs of your viral vector to assist you in the monitoring of potency, identity, residuals and more
  • Characterisation of your viral vector to assist in the determination of capsid content forr downstream processing
  • Presentation on Janssen’s platform controls to aid you in developing them for your own process

2:30 pm
Chair’s Closing Remarks & End of Summit