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AAV Platform Process
UPTEMPO VIRTUOSO™ AAV PLATFORM PROCESS ACCELERATES TIME FROM GENE TO CLINIC

Catalent’s UpTempo Virtuoso™ AAV platform process provides early-stage clients with accelerated timelines for the production of their clinical material. With a simplified supply chain, an increase in development and manufacturing efficiencies and standardized documentation, our scalable, CGMP-ready platform process can significantly reduce the time from gene to clinic.

From plasmid and MCB, platform delivers vialed material for the clinic in 9 months

Table indicating new Uptempo Virtuoso Platform process reduces timeline from 15-18 months to 6-9 months.

The platform process was developed for standard AAV serotypes, including 1, 2, 5, 6, 8, and 9. Starting with CGMP grade plasmid DNA and a master cell bank, the development and manufacturing process is capable of yielding drug product in 9 months.

The suspension-based platform includes a standard set of media, transfection reagents, buffers, and other consumables, greatly simplifying bill of materials and the supply chain. In-house analytical assays help reduce testing timelines.

Simplified Supply ChainDevelopment EfficienciesStreamlined Documentation

Standard raw materials & limited optimization reduce upstream & downstream timelines

  • Suspension-based process at up to 400L scale
  • Single cell line & media
  • Limited transfection optimization
  • Materials on hand, ready for use

    Parallel process & analytical development activities

    • In-house panel of analytics
    • Early development of reference standard
    • Standard qualifications & development experiments
    • Simplified formulation

      Templated documents ease production & record review

      • SOPs
      • Pre-set sampling plan
      • Batch records
      • Technical staff trained on familiar processes, reducing start times & deviations

        Catalent’s platform process partners will also have access to our integrated supply chain of plasmid DNA, potentially further streamlining their timeline.

        The UpTempo Virtuoso™ AAV platform process was developed from the expertise gained supporting over 70 viral vector programs. With our global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, Catalent can provide full supply chain control and support our partners at every stage of the candidate’s journey.