MENUicon menu

Lentiviral vectors for Clinical Applications

The Custom Pre-IND Package is suitable for IND/CTA enabling studies. Our Custom cGMP Package can be scaled to be sufficient for phase I as well as for phase II and III clinical trials.

 

Custom Pre-INDCustom cGMP
Research PhaseIND Enabling Studies *1Clinical Studies (conducted under approved IND)
Advantage
Product*2
Enables you to evaluate several promising 200 mL purified LVFor use in humans, scalable constructs (e.g. 400 mL purified LV)
Service 
Includes
  • Plasmid Prep
  • Small scale evaluation
  • QC analysis
  • Small scale evaluation
  • Full QC analysis
  • Master Batch Record development
  • QA review and disposition
  •  
Documentation
  • Certificate of Analysis
  • Certificate of Analysis
  • Certificate of Conformance
  • Cross Reference Letter to Biologics
  • Master File
  •  
Additional Services
  • Construct design
  • Construct synthesis and cloning
  • Assay development
  • GMP Source Plasmid
  • Assay development
  • Assay qualification
  • Technical lots
  • Stability studies

    *1
    Please check with your regulatory authorithies for specific guidance on your investigational product.

    *2
    Approximate total volumes per lot. Volumes may differ due to concentration and titer requirements.