Workshop B – GMP Commercial Production of Lipid Nanoparticles: Scale up or Scale Out?
Time: 11:30 am - 5:00 pm
day: Pre-Conference Day
Details:
Mostafa Nakach is one of the few industry seasoned experts in LNP field who has seen through LNP and novel biologics scale-up. As your LNP pipeline progresses, the ability to ensure a seamless tech transfer, scale-up efficiency will be critical to support IND filing and commercialisation. Through interactive discussion and a practical case study, you will learn how Mostafa led his Sanofi team to approach GMP manufacturing of LNP and drug product, and equip you with the right parameters whether you are scaling up with your internal capabilities, or looking for outsourced partners.
In this interactive session, you will have the unique opportunity to seek his firsthand advice in:
- Debating the benefits of LNP scaling out and manufacturing in parallel
- Proposing the long-term approach of scaling up and whether scaling outoffers a solution
- Ensuring the consistency of lipid nanoparticle production across parallel systems
- Revealing case studies of the strengths and limitations of the scale up or scale out approach
