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AAV IND-enabling CMC services from plasmid to GMP - ProBio CDMO

AAV IND-Enabling CMC

An end-to-end AAV vector CDMO solution that supports gene therapy developers from early development through GMP manufacturing and regulatory submission.
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AAV Packaging, Process Development & GMP Manufacturing Solutions

Proprietary AAV Packaging Platform

Integrates a triple transient transfection system, AAssistV™ plasmids, and the proprietary PowerS™-293 suspension cell line to support high-titer AAV packaging, process scalability, and GMP-ready vector production.

AAV Manufacturing Expertise

Combining experienced AAV manufacturing scientists, advanced vector characterization technologies, and GMP-compliant production infrastructure to deliver scalable AAV process development, analytical testing, fill-finish services, and clinical-grade vector manufacturing.

Global Readiness

From early development through GMP manufacturing, ProBio offers a globally integrated CMC solution that reduces development complexity, supports regulatory readiness, and ensures reliable delivery of high-quality AAV vectors for clinical advancement.

Plasmid to GMP-Grade AAV in 8 Months

AAV IND-enabling CMC workflow Plasmid to GMP-grade AAV in 8 Months, showing development stages and the manufacturing workflow from Cell Thawing through QC Release. PackingTestDemo Run CellBanking ProcessDevelopment Verification RunEngineeringRun AnalyticalDevelopment GMPManufacturing Stability TestRegulatorySupport To evaluatethe titer andfunction ofAAV Small scaleproductionevaluation •  MCB/WCBConstruction•  Cell BankCharacterization•  Cell BankStability Test •  UpstreamProcessDevelopment•  DownstreamProcessDevelopment•  FormulationProcessDevelopment •  Verification run•  QC and release •  Full scale inclean room,used fortoxicologybatch•  QC and release •  AnalyticalMethodDevelopment•  AnalyticalMethodQualification •  GMPManufacturing•  Quality Controland Release •  AcceleratedStability Test•  InfluencingFactor StabilityTest•  Long-termStability Test •  Report anddocumentpreparationfor regulatoryfiling CellThawingCellExpansion TransfectionLysis andNucleaseClarification PurificationConcentrationBufferExchange SterilizationDS StorageQC Release FormulationSterilizationFill &Finish QCRelease

Case Studies

Case study: High-titer AAV production across multiple serotypes with PowerS™-293

Achieving High-Titer AAV Production Across Multiple Serotypes with the PowerS™-293 Platform

Case study: PowerS™-293 cell density and viability for scalable AAV manufacturing

PowerS™-293 Outperforms Competitor Cell Line with Higher Cell Density, Viability, and Growth Performance for AAV Manufacturing

Resources

Resource flyer: GMP AAV plasmid manufacturing for IND-enabling studies

FLYER

GMP AAV Plasmid Manufacturing

Scale up your AAV plasmid production with phase-appropriate quality grades, analytics, and regulatory support.
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Resource poster: Rapid GMP-grade AAV6 manufacturing platform

POSTER

AAV Manufacturing

Discover a robust, scale-agnostic AAV6 transient transfection platform designed to minimize the primary drivers of scale-up variability.
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Resource flyer: GMP viral vector manufacturing for pre-clinical and clinical use

FLYER

GMP Viral Vector Manufacturing

Your programs are important, and your time is valuable. ProBio is a responsive and reliable CDMO partner of viral vector for pre-clinical, clinical and commercial use.
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Resource poster: PowerS™-ITRrs strain performance for AAV transfer plasmids

POSTER

PowerS™-ITRrs Strain Suitable for Different AAV Transfer Plasmids

Learn more about how the proprietary PowerS™-ITRrs strain delivers high performance with consistent results.
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Request a quote for AAV IND-enabling CMC services - ProBio

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Begin your journey with AAV manufacturing for GMP.
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