Size Exclusion Chromatography (SEC-MALS) Services
ZentriForce Pharma provides specialised analytical services through Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS) – a gold-standard technique for molecular characterisation, aggregate determination, and size distribution analysis. SEC-MALS supports biopharmaceutical development, biosimilarity studies, Adeno-Associated Virus (AAV) development, and peptide characterisation. With state-of-the-art instrumentation and extensive scientific expertise, ZentriForce Pharma delivers precise, reproducible, and regulatory-compliant solutions.
Key SEC-MALS Outputs Include:
- Molecular weight (Mw) and radius of gyration (Rg)
- Relative concentrations of species
- Aggregation profiles
- High-resolution fractograms for complex biopharmaceuticals
Why Choose SEC-MALS Services at ZentriForce Pharma?
Extensive expertise: Scientific team experienced across monoclonal antibodies, biosimilars, AAVs, peptides, and protein therapeutics.
Advanced instrumentation: Agilent 1260 Infinity II HPLC coupled with Wyatt DAWN Heleos II MALS and Wyatt Optilab T-rEX RI detectors, offering high sensitivity and reproducibility.
Flexible operation: Vial-based analysis at temperatures from 10 °C to 85 °C, tailored to column specifications and sample type.
Regulatory-ready results: Methods developed, qualified, and validated per ICH guideline Q2 for regulatory compliance.
Robust and reliable: Accurate molecular weight determination without reliance on calibration standards, mitigating potential misinterpretation from stationary phase interactions.
Quality and compliance: WHO-aligned quality management system with over 30 SOPs, operated by qualified personnel to ensure accuracy, reproducibility, and full audit support.
Technical SEC-MALS Specifications
| Main Output | fractogram (relative concentrations); molecular weight (Mw) |
| Size range | 1 kDa to 5 MDa |
| Additional Outputs | radius of gyration (rg) |
| Sample Volume | depending on the column |
| Measurement type | vial based |
| Temperature range | 10°C to 85°C |
Applications of SEC-MALS
Biopharmaceutical Development
SEC-MALS is the preferred approach for aggregate determination in therapeutic protein development. ZentriForce Pharma integrates MALS detection to accurately measure molecular weights of eluted species, ensuring reliable characterisation of monoclonal antibodies, enzymes, and protein therapeutics. Customised method development, routine analytical measurements, and regulatory-compliant validation support formulation optimisation and quality control.
Biosimilarity Studies
SEC-MALS provides high-resolution aggregate profiles for biosimilar candidates versus reference products. ZentriForce Pharma delivers precise molecular weight and size distribution data to support comparability studies, enabling clients to confidently demonstrate biosimilarity in regulatory submissions. Methods are tailored, validated, and qualified according to ICH Q2 standards.
Adeno-Associated Virus (AAV) Development
SEC-MALS enables accurate aggregate and molecular weight analysis in AAV gene therapy vectors, overcoming challenges from limited column size ranges. ZentriForce Pharma offers specialised method development, MALS integration, and service measurements to ensure precise characterisation, supporting high-quality gene therapy development.
Peptide Development
Peptides present unique analytical challenges due to their small size and low resolution. SEC-MALS methods developed by ZentriForce Pharma ensure accurate measurement of peptide aggregates and molecular weight distributions, supporting formulation development and regulatory-compliant method qualification.
Partner with ZentriForce Pharma
By combining SEC-MALS with complementary analytical techniques such as SV-AUC, μ-DSC, AF4, and others, ZentriForce Pharma delivers a complete suite of biopharmaceutical characterisation solutions. Our expertise, advanced instrumentation, and regulatory-ready workflows make us a trusted partner for companies seeking precise, high-resolution, and cost-efficient analytical services.
📩 Contact ZentriForce Pharma today to discuss how SEC-MALS can support your development program. Email info@zentriforce.com or complete the Quick Contact Form on our website.
