Dynamic Light Scattering (DLS) Services
ZentriForce Pharma provides Dynamic Light Scattering (DLS) services for rapid and sensitive particle size, aggregation, and stability analysis in biopharmaceuticals, biosimilars, and gene therapy products.
DLS Services for Particle Size and Stability Assessment
Dynamic Light Scattering (DLS) measures the hydrodynamic radius of particles in solution, detecting aggregates and impurities across a wide range from 0.5 nm to 1 µm. It bridges the gap between small soluble aggregates identified by size exclusion chromatography (SEC) and larger particles assessed by light obscuration (LO) or micro flow imaging (MFI). By combining DLS with Static Light Scattering (SLS) and zeta-potential analysis, ZentriForce Pharma provides a comprehensive understanding of particle size distributions, molecular weight, and colloidal stability.
Why Choose DLS Services at ZentriForce Pharma?
- Broad measurement range: Detects particles and aggregates from 0.5 nm to 1 µm in diameter, covering critical biopharmaceutical and gene therapy species.
- Comprehensive data outputs: Integration of DLS, SLS, and zeta-potential delivers size, molecular weight, and stability insights.
- Advanced instrumentation: DynaPro® Plate Reader III for ultra-low sample volumes (from 4 µL) and high-throughput well-plate formats; Malvern Zetasizer Lab for zeta-potential analysis.
- Flexible workflows: Temperature-controlled measurements (4 °C – 85 °C) with options for temperature ramps and isothermal monitoring.
- Regulatory alignment: Methods developed, qualified, and validated in line with ICH Q2 guidelines, supported by SOPs and full audit readiness.
- Expertise across applications: Extensive experience in biosimilarity studies, AAV development, viral vectors, and other gene therapy APIs.
Dynamic Light Scattering Specifications
| Main output | Size distribution (rH or dH); molecular weight (Mw) |
| Size range | 0.5 – 1000 nm; 1 kDa to 1 MDa |
| Additional outputs | Temperature stability (Tonset, Tm, Tagg); Interaction parameter (A22, kD) |
| Sample volume | 4 µL to 150 µL |
| Measurement type | well plate (96, 384 or 1536 wells) |
| Temperature range | 4°C to 85°C |
Applications of DLS
Biopharmaceutical Development
DLS is applied to rapidly screen formulations, providing particle size distributions, aggregate detection, and stability insights. Its high sensitivity supports early formulation optimisation, ensuring product integrity and identifying potential impurities across 0.5 nm – 1 µm. Combined DLS/SLS and zeta-potential analyses offer a holistic view of particle characteristics for robust formulation development.
Biosimilarity Studies
DLS enables comparability assessments of biosimilars, bridging the detection range between SEC and LO/MFI. Method development and qualification in line with ICH Q2 guidelines, along with SOP creation, ensure reliable and regulatory-compliant results. Temperature-controlled measurements further support stability assessment and comparability claims.
Gene Therapy Development
From small DNA/RNA complexes to adeno-associated viruses (AAVs) and larger viral vectors, DLS characterises particle size distributions and thermal stability. Integration with zeta-potential analysis provides additional insights into particle stability and charge. Temperature ramps and isothermal monitoring allow high-throughput assessment of gene therapy products under controlled conditions.
Quality and Expertise You Can Trust
- BSL-1 and BSL-2 facilities for handling a diverse range of biopharmaceutical materials.
- WHO-aligned quality management system with nearly 30 SOPs for methods, equipment, and analytics.
- Dedicated quality manager ensuring compliance, staff training, and equipment qualification.
- Audit-ready environment with transparent processes and complete data traceability.
Partner with ZentriForce Pharma
By combining DLS with complementary methods such as SEC-MALS, SV-AUC, μ-DSC, and AF4, ZentriForce Pharma delivers an advanced suite of analytical solutions for biopharmaceutical development.
📩 Contact ZentriForce today to learn how DLS can support your biosimilarity, gene therapy, or biopharmaceutical project. Please email ZentriForce’s experts at info@zentriforce.com or complete the Quick Contact Form.
