Protein Characterisation Services
ZentriForce Pharma specialises in protein characterisation using hydrodynamic techniques and light-scattering methods to assess critical quality attributes for biopharmaceutical development, biosimilarity programmes and gene-therapy products. The service offering combines orthogonal, complementary methods to deliver a detailed picture of aggregation, size distribution, molecular weight, purity and higher-order structure, information that is central to development, comparability, and regulatory dossiers. ZentriForce employs advanced techniques, including SV-AUC, AF4, DLS, SEC-MALS, and µ-DSC to provide exceptionally robust and reliable protein characterisation for the pharmaceutical industry.
Comprehensive Protein Characterisation Services
Protein therapeutics present a range of analytical challenges: aggregation, fragmentation, conjugation, and subtle changes in higher-order structure can all affect safety and efficacy. ZentriForce Pharma applies multiple, orthogonal techniques to detect, quantify and characterise these attributes under native-like conditions so clients obtain robust, regulatory-ready data.
Key Analytical Techniques Offered
Analytical Ultracentrifugation (AUC)
- Sedimentation Velocity (SV-AUC): High-resolution separation by size and density to determine fragment and aggregate populations, sedimentation coefficients, approximate molecular weight, and shape information.
- Sedimentation Equilibrium (SE-AUC): A first-principles approach for determining the absolute molecular weight of the API in solution.
Asymmetrical Flow Field-Flow Fractionation (AF4-MALS)
- Gentle, column-free fractionation across a broad size range (approximately 1 nm – 1 µm diameter).
- When coupled with light-scattering and UV detection, it supports hydrodynamic radius determination, size distribution, molecular weight, and aggregate/fragment profiling without stationary-phase artefacts.
- Suitable for protein conjugate analysis (e.g., PEGylated proteins, antibody–drug conjugates, polysaccharide–protein conjugates), enabling evaluation of size distribution, conjugation heterogeneity, and aggregation behaviour.
Light Scattering Techniques
- Dynamic Light Scattering (DLS): Rapid hydrodynamic sizing and polydispersity screening across the 0.5 nm – 1 µm range for fast formulation or stability checks.
- Static Light Scattering (SLS): Provides molecular-weight information and complements DLS for reliable mass and size characterisation.
Size Exclusion Chromatography with Multi-Angle Light Scattering (SEC-MALS)
- A routine, well-established separation method for aggregate determination.
- Coupling SEC with MALS yields accurate molecular weights and oligomeric-state information for eluted species, supporting method qualification and quality control.
- Suitable for protein conjugates (e.g., PEGylated proteins, antibody–drug conjugates, polysaccharide–protein conjugates), enabling evaluation of conjugation state, distribution of conjugated species, and aggregate formation.
- Complements AF4 measurements and supports comparability studies, formulation screening, and batch consistency assessments.
Micro-Differential Scanning Calorimetry (µ-DSC)
- Provides precise determination of melting temperature (Tm), onset temperature, and unfolding transitions, supporting formulation and comparability studies.
- Detects changes in higher-order structure, enabling evaluation of stability under different buffer conditions, excipients, or processing steps.
- Serves as a useful orthogonal measure of higher-order structure and provides a distinctive thermodynamic fingerprint for biosimilarity and formulation studies.
Quality Attributes Assessed
- Aggregate quantification and detailed aggregate characterisation
- Size distribution and polydispersity
- Absolute and relative molecular weight determination
- Purity and fragment profiling
- Conjugate analysis
- Higher-order structure and thermal stability metrics
Why Choose Protein Characterisation Services at ZentriForce Pharma?
- Hydrodynamic and orthogonal expertise: A focus on hydrodynamic approaches (AUC, AF4) combined with light-scattering and thermal methods produces high-confidence data with minimal method-dependent bias.
- Comprehensive, complementary analytics: Orthogonal techniques are combined to cross-validate findings and strengthen comparability and stability claims.
- Regulatory readiness: Method development and qualification workflows are designed to support regulatory submissions and comparability packages.
- Tailored workflows: Methods are adapted to the protein’s size, formulation and intended analytical question (aggregate detection, higher-order structure, conjugate analysis, etc.).
- Traceable data and reporting: Deliverables include raw and processed data, method documentation and reports suitable for inclusion in regulatory dossiers.
Techniques Employed in Protein Characterisation
| Technique | Utility for Proteins |
|---|---|
| SV-AUC | Determines fragments and aggregates; provides sedimentation coefficients, molecular weight, and shape information in native solution. |
| SE-AUC | First-principles determination of absolute molecular weight of the API in solution. |
| AF4-MALS | Stationary-phase-free separation; characterises species from ~1 nm to 1 µm, ideal for heterogeneous protein or gene-therapy samples. |
| DLS | Rapid screening of size distribution and aggregate behaviour from 0.5 nm to 1 µm. |
| SLS | Determines the molecular weight of species when combined with DLS. |
| SEC-MALS | Standard aggregate quantification technique; MALS enables accurate molecular weight determination of all eluting species. |
| µ-DSC | Assesses thermal stability and higher-order structural transitions; provides unique “structural fingerprints” for biosimilarity and formulation studies. |
Quality Assurance and Data Integrity
ZentriForce Pharma operates a formal quality system with SOPs governing method execution, instrument maintenance, data handling and reporting. Services are delivered in an audit-ready framework to ensure reproducibility, traceability and confidentiality of analytical results.
Partner with ZentriForce Pharma
By integrating SV-AUC, DLS/SLS, SEC-MALS, AF4 and µ-DSC into tailored orthogonal workflows, ZentriForce Pharma provides authoritative protein characterisation services to support development, biosimilarity assessments and regulatory submissions.
📩 Contact ZentriForce Pharma Research to explore how their protein characterisation services can support your project. Please complete the Quick Contact Form or email info@zentriforce.com
