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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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