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AAV Plasmid CMC to GMP Services – Scalable GMP Plasmid Manufacturing for Gene Therapy

AAV Plasmid CMC to GMP

High quality and scalable yield pDNA for AAV, with reliable and fast supply from IIT preclinical research through commercial production.

IND-Enabling CMC in as Fast as 2 Months

AAV Plasmid CMC to GMP Workflow Six-stage workflow covering cell banking, process development, analytical development, plasmid manufacturing, stability study, and IND documentation. Cell Banking ProcessDevelopment AnalyticalDevelopment PlasmidManufacturing Stability Study IND Documentation •  Research Cell Bank•  Primary Cell Bank•  Master Cell Bank•  Working Cell Bank •  Upstream ProcessDevelopment•  Downstream ProcessDevelopment•  Formulation Study•  Verification Run •  Analytical MethodDevelopment•  Analytical MethodQualification•  Project SpecificQualification •  PreCMC PlasmidManufacturing•  GMP–PrinciplePlasmid Manufacturing•  GMP PlasmidManufacturing •  Long–Term Stability•  Accelerate Stability•  Influencing FactorStability •  CTD Format
Case Study – PowerS™-ITRrs Delivers Superior ITR Stability for AAV Plasmid Manufacturing
Resource Flyer – Gene Therapy Solutions for Plasmid and AAV Production
Poster Resource – PowerS™-ITRrs Strain for AAV Transfer Plasmids
GMP Viral Vector Manufacturing
GMP Plasmid Manufacturing
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