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Analytical & QC

OverviewCapabilitiesAnalytical MethodStability & Comparability

Overview

Analytical and QC testing supports the development of targeted lentiviral vectors (LVVs) for in vivo CAR-T applications, from early-stage characterization through preclinical studies to GMP-oriented development.

Our approach connects vector quality, safety, targeting performance, and functional activity. Analytical panels are selected according to vector design, development stage, and study objectives—ensuring that data generated at each step builds toward a coherent CMC and regulatory package.

Integrated Analytical Workflow

We establish a stage-appropriate analytical workflow to evaluate targeted LVVs and their biological performance.

This workflow can be adapted to support different stages of targeted LVV-based in vivo CAR-T development.

Our Analytical & QC Capabilities

Vector Quality & Release

Our capabilities cover key physical, molecular, and microbiological attributes of LVV preparations.

  • Physical and functional titer
  • p24-based particle quantification
  • Vector genome quantification
  • Vector integrity and particle characterization
  • Host-cell protein and residual host-cell DNA
  • Residual plasmid DNA and process-related impurities
  • Endotoxin​ (LAL), mycoplasma, sterility

Safety & Genomic Characterization

We evaluate vector-associated safety attributes and genomic characteristics relevant to lentiviral vector development.

  • Replication-competent lentivirus (RCL)
  • Vector copy number (VCN)
  • Integration site analysis
  • IS-seq / LAM-PCR
  • Integration profile characterization
  • Clonal expansion assessment, where applicable

Potency & Functional Bioanalysis

Our cell-based assays assess vector activity and downstream CAR-T-related functional responses.

  • Transduction efficiency
  • CAR-positive cell generation
  • CAR expression
  • Target-cell-specific cytotoxicity
  • T-cell activation
  • Cytokine secretion
  • Targeting specificity
  • Functional potency

Targeting & CAR-Related Assessment

For targeted LVV-based in vivo CAR-T programs, we can evaluate key attributes connecting vector targeting with CAR-T generation and function.

  • Target-cell binding and recognition
  • Targeted versus non-targeted transduction
  • CAR expression and expression level
  • CAR-positive cell populations
  • Target-cell-specific activity
  • On-target / off-target transduction assessment, where applicable

Multi-Dimensional Analytical Characterization

We combine complementary analytical approaches to characterize targeted LVVs across molecular, physicochemical, cellular, functional, and tissue levels.

Molecular Characterization

  • qPCR / ddPCR
  • Sanger sequencing
  • NGS
  • Vector genome and transgene analysis
  • Vector copy number and integration site analysis

Physicochemical Characterization

  • p24-based particle quantification
  • Particle size and distribution
  • Vector integrity
  • Purity and aggregation assessment

Cell-Based Characterization

  • Flow cytometry
  • Transduction efficiency
  • CAR expression
  • Cell phenotype and activation
  • Target-cell-specific responses

Functional Characterization

  • Cytotoxicity / killing assays
  • CAR-mediated T-cell activation
  • Cytokine profiling
  • Functional potency assessment

Tissue-Level Characterization

  • IHC
  • IF
  • RNAscope
  • Tissue distribution and CAR/vector-related marker analysis

Stability & Comparability 

We assess changes in vector quality and functional activity during storage and following process or manufacturing changes.

Stability Assessment

  • Storage stability
  • Freeze-thaw stability
  • Post-thaw quality
  • Temperature excursion studies
  • Stability-indicating quality and potency attributes

Comparability Assessment

  • Batch-to-batch consistency
  • Process change comparability
  • Scale-up comparability
  • Formulation change assessment
  • Impact of raw material or process changes

Testing panels are selected based on the product characteristics and development stage.

Our Analytical Support from Development to GMP

Our analytical testing is tailored to the vector characteristics and development stage, supporting targeted LVV programs from early characterization to GMP-oriented development.

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Preclinical Development

  • Quality and safety characterization
  • Genomic analysis
  • Functional potency
  • Stability and comparability
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Early Development

  • Vector characterization and titer
  • Transduction and CAR expression
  • Preliminary potency assessment
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GMP-Oriented Development

  • Analytical method development
  • Method qualification / validation, where applicable
  • In-process and release testing
  • QC documentation and CoA

Get Started Today

Need analytical support for your targeted LVV program? Contact us to discuss how our characterization, potency, and GMP QC capabilities can align with your development stage and regulatory timeline.

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* For research use only. Not intended for any clinical use.
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