Vector Nucleic Acid Quality Control Platform
Vector Nucleic Acid Quality Control Platform
What ultimately determines the efficacy and safety of a delivery vector is the molecular identity of the nucleic acid packaged inside the particle — whether the intended genome is fully intact or compromised by truncation, aberrant splicing and chimerism (integrity), and whether the particle is contaminated by residual production plasmid, endogenous/exogenous viral sequences or host-cell DNA (purity). Conventional approaches such as gel electrophoresis, qPCR and short-read sequencing struggle to resolve full-length structure, splice junctions and strong secondary-structure regions like ITRs at single-molecule resolution — which is precisely why the long-standing gap between physical titer and functional titer often remains unexplained.
ZhuHai GeneRulor's Vector Nucleic Acid QC Platform uses third-generation long-read sequencing (Oxford Nanopore / PacBio) as its technical core, with Illumina short-read sequencing for orthogonal validation. Following the product chain of source plasmid → viral particle → integration and transcription, the platform delivers a fully integrated portfolio of ten assays covering lentivirus (LVV), AAV and CAR-T products, including full-length plasmid sequencing and identity confirmation, AAV ITR integrity and symmetry analysis, lentiviral RNA integrity and splicing/variant analysis, lentiviral particle nucleic acid composition and purity analysis, AAV genome integrity (with optional ITR characterization), vector integration site and proviral structure analysis, and full-length transcript profiling with isoform/expression analysis. Each assay is mapped to specific regulatory requirements under ICH Q5A(R2) / Q5B / Q6B / Q2(R2) / S12, FDA CAR-T and long-term follow-up guidances, and NMPA/CDE technical guidelines, generating CQA-grade quantitative readouts (full-length rate, Ψ-positive ratio, ITR integrity, chimeric fraction, vector copy number, etc.). The platform supports fit-for-purpose method qualification at IND stage and full ICH Q2(R2) method validation at BLA stage, providing a single-molecule evidence chain for vector CMC characterization, batch release and dual-region (China / US) regulatory submission.
