Gene Therapy Product Analytics

ZentriForce Pharma Research provides comprehensive analytical support for gene therapy product development, combining hydrodynamic and orthogonal techniques to characterise complex viral and non-viral APIs. Gene therapy products require precise analysis of not only product purity but also key quality attributes such as the ratio of full to empty capsids and the distribution of carrier particles loaded with nucleic acids. Drawing on extensive experience with DNA/RNA complexes, liposomal carriers, adeno-associated viruses (AAVs), and larger viral systems, ZentriForce Pharma delivers regulatory-ready data to advance your gene therapy programs.

Gene Therapy Product Analytics for Complex APIs

Gene therapy development presents unique analytical challenges that demand both technical expertise and a multi-technique approach. ZentriForce Pharma employs complementary methods, including sedimentation velocity analytical ultracentrifugation (SV-AUC), asymmetrical flow field-flow fractionation (AF4), and dynamic light scattering (DLS), to provide a comprehensive understanding of your product’s composition, purity, and stability. These methods together provide information on particle size, aggregation behaviour, and molecular integrity, addressing critical quality attributes across the full range of gene therapy modalities.

Why Choose ZentriForce Pharma for Gene Therapy Analytics

• Broad analytical scope: Expertise spanning small DNA/RNA complexes, liposomal carriers, AAVs, and full viral APIs up to several hundred nanometres in size.
• Comprehensive characterisation: Determination of particle size, purity, sedimentation coefficient, and full-to-empty particle ratios using orthogonal techniques.
• Regulatory readiness: Method development and qualification following ICH Q2(R1), ensuring data integrity and compliance.
• Innovative instrumentation: Advanced platforms including Optima AUC, Wyatt Eclipse AF4, Agilent 1260 Infinity II HPLC with MALS/RI, and DynaPro Plate Reader III for simultaneous DLS/SLS.
• Collaborative scientific expertise: A team experienced in gene therapy product analytics, offering custom-tailored workflows to meet unique molecular requirements.

Core Analytical Techniques for Gene Therapy Products

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC)

SV-AUC is a first-principles technique that separates species by both size and density, providing unparalleled resolution for determining the ratio of empty to full capsids and assessing product purity. ZentriForce Pharma applies SV-AUC to DNA/RNA complexes, AAVs, lysosomal formulations, and complete viruses, generating data on molecular weight, sedimentation coefficients, and UV signal ratios (260/280 nm).

Applications include:

• Full-to-empty particle ratio determination
• Aggregate detection and purity profiling
• Stability and comparability assessments

Asymmetrical Flow Field-Flow Fractionation (AF4)

AF4 enables gentle, high-resolution separation of gene therapy products over a wide range (1 nm – 1 μm) without stationary-phase interactions. Coupled with MALS and dual UV (260 nm + 280 nm) detection, AF4 quantifies intact APIs, fragments, and aggregates in a single run.

Applications include:

• AAV and viral particle fractionation
• DNA/RNA complex analysis
• Evaluation of particle heterogeneity and aggregation states

Dynamic Light Scattering (DLS)

DLS provides rapid, non-invasive screening for aggregate and particle detection, bridging the analytical range between SEC and micro-flow imaging (MFI). It supports both early formulation screening and advanced stability testing.

Applications include:

• Particle size distribution and aggregation monitoring (0.5 nm – 1 µm)
• Zeta-potential analysis for charge-related stability
• High-throughput stability and temperature ramp studies

Nanoparticle Tracking Analysis (NTA)

NTA enables precise, real-time visualisation and quantification of nanoparticles in liquid suspension, offering high-resolution particle size and concentration measurements. It complements DLS and AF4 by providing direct number-based particle distributions.

Applications include:

• Particle size and concentration determination (30 nm – 1 µm)
• Assessment of sample heterogeneity and polydispersity
• Temperature-controlled studies for evaluating sample stability and aggregation behaviour

Videodrop Analysis 

Videodrop analysis provides label-free, real-time visualisation and quantification of nanoparticles in their native buffer, combining particle tracking with video microscopy. This technique enables rapid measurement of particle size and concentration without the need for dilution or staining.

Applications include:

• Particle size and concentration analysis (80 nm – 500 nm)
• Characterisation of viral vectors, extracellular vesicles, and liposomes
• Monitoring of sample stability under native conditions
• Assessment of sample heterogeneity and polydispersity

Applications of Gene Therapy Analytics

Adeno-Associated Viruses (AAV)

AAVs are a central focus in modern gene therapy. Due to their non-pathogenic nature, mild immunogenicity, and small particle size (~22 nm), they are relatively straightforward to analyse. ZentriForce Pharma applies SV-AUC, AF4, and DLS to determine capsid integrity, full-to-empty ratios, and stability, supporting robust product development and comparability studies.

Other Viruses

Non-AAV viral APIs often span several hundred nanometres, requiring adapted analytical strategies. ZentriForce Pharma tailors analytical workflows to each viral system’s unique physicochemical properties, employing techniques like AF4 and SV-AUC for accurate assessment of purity, aggregation, and molecular integrity.

Other Gene Therapy Products

Beyond viruses and AAVs, ZentriForce Pharma supports diverse gene therapy APIs, including DNA/RNA complexes and liposomal or lysosomal carrier systems. Combining AF4, DLS, and SV-AUC, the company provides comprehensive profiling of size, charge, purity, and thermal stability for novel and evolving therapeutic platforms.

Quality and Expertise You Can Trust

• BSL-1 and BSL-2 facilities for safe handling of viral and non-viral gene therapy materials.
• Formal WHO-aligned quality management system with nearly 30 SOPs covering methods, instrumentation, and data handling.
• Dedicated quality manager overseeing compliance, qualification, and training.
• Audit-ready environment with full traceability, transparent documentation, and regulatory support.

Partner with ZentriForce Pharma

By integrating SV-AUC, AF4, NTA, Videodrop and DLS with complementary analytical technologies, ZentriForce Pharma delivers a comprehensive suite of gene therapy product analytics to support characterisation and regulatory submissions.

📩 Contact ZentriForce Pharma today to learn how the company’s expertise in Gene Therapy Analytics can accelerate your product development. Please email the ZentriForce team at info@zentriforce.com or complete the Quick Contact Form.