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Modality-specific analytical strategy
Analytical control strategies shaped around LVV, AAV, and targeted LNP/RNA products, manufacturing stages and critical quality attributes.
CGT · MOLECULAR ANALYTICAL DEVELOPMENT
Analytical confidence.
For next-generation therapies.
Independent scientific consulting for cell and gene therapy programs — specializing in LVV, AAV and targeted LNP/RNA platforms, with NGS, digital PCR and qPCR at the center of analytical development.
Modality-informed methods · Purpose-built assays · Decision-ready science
CELL & GENE THERAPY GENOMETRION / 004
LVV ✧ AAV ✧ RNA DELIVERYFIG. 01
ANALYTICS
BY DESIGN↗
BY DESIGN↗
Lentiviral vectors
AAV platforms
tLNP / RNA therapeutics
01 / CGT01 / SPECIALIST CONSULTING
Engineered therapies.
Purpose-built analytics.
Independent scientific guidance across viral-vector, nanoparticle and RNA modalities—from assay concept through analytical readiness.
02
NGS method development
Sequencing strategy, library design considerations, quality controls, data interpretation and fit-for-purpose genomic characterization.
03
dPCR, qPCR & RT-qPCR assay design
Target and primer/probe selection strategy, quantification workflows, reference controls, assay suitability and performance evaluation.
04
Analytical lifecycle & technical assessment
Risk-based gap analyses, feasibility planning, comparability considerations, troubleshooting and method-transfer readiness.
Proposed advisory services. Method design and technical assessment do not imply in-house laboratory testing, certified QC testing, or regulatory approval.
02 / THERAPEUTIC MODALITIES
Different delivery systems.
Different analytical questions.
Each modality brings unique matrices, biological risks and measurement challenges. Genometrion designs the analytical strategy around the product—not the other way around.
Lentiviral vectors
Genomic and molecular analytics for vector production and gene-modified cell therapies.
Adeno-associated viral vectors
Assay strategies for genome titer, identity, packaged-genome integrity and product heterogeneity.
Targeted LNP & RNA therapeutics
RNA-focused assays alongside an integrated view of delivery-related analytical attributes.
Scientific illustrations supplied for the website are conceptual, not molecular-scale or structurally validated depictions. Molecular assays complement—but do not replace—orthogonal methods for particle properties, encapsulation, lipid composition, or biological activity.
03 / ANALYTICAL PLATFORMS
The right technology.
The right answer.
Genomic methods are most useful when linked to a defined analytical question, suitable controls and a defendable interpretation framework.
NGSSEQUENCE-RESOLVED ANALYTICS
Next-generation sequencing
Design considerations for targeted and broader sequencing strategies, sample preparation, coverage, assay controls, bioinformatics and data interpretation.
- Vector genome identity and integrity
- Insertion-site or integration profiling where relevant
- Sequence heterogeneity and analytical interpretation
dPCRABSOLUTE NUCLEIC-ACID QUANTIFICATION
Digital PCR / ddPCR
Fit-for-purpose strategies for absolute copy-number measurement, reference gene normalization, sample matrix effects and data-quality assessment.
- Vector genome titer and vector copy number
- Residual nucleic acid targets
- Controls, precision and detection capability
qPCRREAL-TIME AMPLIFICATION ANALYTICS
qPCR / RT-qPCR
Quantitative assay architecture, standard curve considerations, assay efficiency, target specificity, reverse-transcription design and inhibition controls.
- DNA/RNA target measurement
- Assay sensitivity, specificity and range
- Reference standards and trend interpretation
Scientific charts above illustrate analytical principles only. They are not measured, generated or validated experimental data.
04 / METHOD DEVELOPMENT
From critical attribute
to fit-for-purpose assay.
An analytical blueprint that connects intended use, method selection, assay architecture, and lifecycle evidence.
01◎
Define
Intended use, quality attribute, sample matrix, decision threshold
02⌁
Select
NGS, dPCR, qPCR or orthogonal methods for the analytical question
03⌘
Design
Targets, controls, sample preparation, readout and data analysis
04▥
Evaluate
Specificity, precision, accuracy, range, sensitivity and robustness as relevant
05↗
Translate
Document, troubleshoot, assess comparability and plan transfer readiness
ILLUSTRATIVE ASSAY MAPPING
Questions that drive method selection
Representative matches for scoping discussions; final platform choice depends on product, sample, stage and performance requirements.
| Modality | Analytical question | Candidate approach |
|---|---|---|
| LVV / engineered cells | Integrated vector copy number? | dPCR / qPCR |
| LVV / engineered cells | Where did vector integration occur? | Targeted NGS-based profiling |
| AAV | Vector genome titer? | dPCR / qPCR |
| AAV | What is the packaged genome sequence profile? | NGS-based characterization |
| tLNP / RNA | How much target RNA is present? | RT-qPCR / RT-dPCR |
| tLNP / RNA | How are lipid particles and encapsulation characterized? | Orthogonal physicochemical assays |
General frameworks such as ICH Q14 and Q2(R2) inform development and validation thinking; applicability and evidence requirements depend on the specific product, purpose and regulatory context.
RESEARCHEVIDENCEIMPACT
INSIGHT THROUGH SCIENTIFIC RIGOR
05 / ABOUT GENOMETRION
Focused on advanced therapies.
Grounded in molecular science.
Developing a cell or gene therapy requires more than a collection of tests. Analytical evidence must be connected to the product modality, its intended use and the decisions required at each stage of development.
Genometrion is being developed as an independent scientific consulting company centered on advanced therapies, genomic analytical development, and fit-for-purpose molecular method design.
Attribute-driven decisions
Start with the quality attribute and intended use, then select the most informative measurement strategy.
Orthogonal scientific thinking
Integrate genomic methods with complementary characterization, risk assessments and assay controls.
Transferable analytical knowledge
Documented rationale, study designs, controls, risks and next-step recommendations.
06 / HOW WE WORK
A structured path
from question to action.
Modality-informed technical reviews, method-design engagements and strategic assessments for cell and gene therapy programs.
01
Frame
Define the product, quality attribute, analytical question, decision context and deliverables.
02
Assess
Evaluate technology fit, assay limitations, controls and performance evidence across relevant methods.
03
Recommend
Provide a method-development roadmap, assay architecture or decision-ready technical assessment.
WHO WE AIM TO SUPPORT
For teams turning
science into progress.
Gene therapy developersCGT analytical teamsRNA / delivery innovatorsCDMOs & scientific partners
07 / ENGAGEMENT FORMATS
Scientific rigor.
Usable outcomes.
Engagements can be scoped to a single technical decision or a broader analytical challenge. These are examples of potential deliverables, not completed client projects.
EXAMPLE FORMAT
Analytical method design consultation
Focused design discussion covering intended use, analytical targets, critical controls and a development plan.
Potential output: assay design outlineEXAMPLE FORMAT
NGS / PCR technical assessment
Cross-platform NGS / PCR method review, quality attribute mapping, suitability gaps and recommended follow-up studies.
Potential output: analytical gap reportEXAMPLE FORMAT
CGT analytical strategy workshop
A facilitated roadmap to align modality-specific assay priorities, development stages and transfer requirements.
Potential output: decision roadmapSCIENTIFIC CONTEXT
Built around evidence and analytical principles.
Method-development thinking can draw on the ICH analytical lifecycle framework and gene-therapy CMC guidance. Referenced material is general background, not a claim of certification or regulatory endorsement.
08 / CONTACT
Your therapy is complex.
Your analytics can be clear.
From LVV vector-copy assays and AAV genome characterization to RNA-based therapeutics: begin with the scientific question your program needs answered.
PRE-LAUNCH
Let’s start with the question.
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