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"Validating LV gene therapy processes for FDA & EMA approval"

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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. 

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

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