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Discover AGCellerate™ for LVV - a faster option to get your GMP-ready lentiviral vector product   Learn about AGCellerate
Webinar: June 13 at 8:00 am PT
Uncharted paths:

Successfully validating your LV gene therapy product process to gain FDA and EMA approval 


Register to attend!

Can't make it? Register and receive the recording to watch whenever fits your schedule best. 

Webinar Overview: 

Process validation in cell and gene therapy development is complex and full of uncertainty. In this relatively untested space, identifying and employing the best practices to advance a therapy from concept to market can feel impossible - but it doesn't have to be!

Lenmedly™, a hematopoietic stem cell (HSC) gene therapy from Orchard Therapeutics, is the first gene therapy to achieve FDA and EMA approval for treatment of metachromatic leukodystrophy (MLD). 

AGC Biologics' experienced Cell and Gene CDMO team in Milan provided end-to-end support for the drug product through development, clinical stages, CMC strategy, and commercialization in the context of regulatory approval. 

We'll walk through the process our leading team uses to produce lentiviral vector-based products that can scale at any stage and meet rigorous regulatory demands. 

Join and learn how to ease your product's journey by:

  • Investing to empower your Stage 1 activities  
  • Strategic planning of Stage 2 and 3 timelines
  • Leveraging the knowledge and data available for the platform process approach  
  • Continuous support from analytics: platform methods and in-house testing are preferred   
  • Creating a strong scientific and statistical justification of the specifications set  
  • Understanding final considerations for regulatory review and approval stages 

Join our industry expert speakers

From AGC Biologics Cell & Gene Center of Excellence in Milan

Francesca Rossetti headshot

Francesca Rossetti

Analytical Method Development Director

Read Francesca's Bio
Monika Pema

Monika Pema

Senior Manager MSAT

Read Monika's Bio

Additional Cell & Gene Therapy

Educational Content

Like a Tailored Suit download graphic no iconBuilding Customized Viral Vector Programs

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Outsourcing Allogeneic Cell Therapy - download graphic no iconAccelerating Allogeneic Cell Therapies 

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large-scale aav manufacturing download graphic no iconCreating a Large-Scale AAV Platform

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