Peptide Drug Analysis Services

ZentriForce Pharma Research, a contract research organisation (CRO) with deep expertise in hydrodynamic orthogonal analytical methods, offers a full suite of peptide drug analysis services tailored for development, biosimilarity and regulatory support. Drawing on its experience with challenging peptide APIs, including glatiramer acetate and other therapeutic peptides, ZentriForce Pharma combines sedimentation velocity analytical ultracentrifugation (SV-AUC), dynamic light scattering (DLS), size-exclusion chromatography with multi-angle light scattering (SEC-MALS), asymmetrical flow field-flow fractionation (AF4), µ-differential scanning calorimetry (µ-DSC) and fractionation workflows to provide physicochemical and stability characterisation from approximately 1 kDa upwards.

ZentriForce Pharma emphasises method development and method qualification, operates a formal SOP-based quality system, and performs in-house data evaluation to deliver reproducible, regulatory‑ready results.

SV-AUC for Peptide Aggregation and Purity Analysis

• First-principles, a high-resolution technique for purity and aggregation assessment.
• Advanced data evaluation workflows ensure reliable analysis of small peptides.
• Performed on high-performance Optima analytical ultracentrifuges with traceable data evaluation using established software packages.

DLS and SLS Particle Sizing for Peptides

• Rapid screening of particle size distributions and colloidal stability.
• Integration with zeta-potential analysis for insights into aggregation and repulsive interactions.
• Bridges the analytical gap between small soluble aggregates and larger particles.
• Supports formulation screening and orthogonal confirmation of aggregation behaviour.

SEC-MALLS for Peptide Molecular Weight and Oligomeric State

• Tailored SEC-MALLS workflows optimised for peptide samples.
• Molecular weight determination, oligomeric-state assessment, and recovery profiling.
• Specialised handling for low-molecular-weight peptides where separation and detection can be challenging.

AF4 for Fragile Assemblies and Mixtures

• Column-free fractionation method to separate peptide assemblies and aggregates without stationary-phase interactions.
• Enables subsequent characterisation by light scattering and UV detection.
• Particularly suitable for fragile or heterogeneous peptide systems.

Temperature Stability Testing (Tonset, Tm, Tagg)

• Temperature-controlled stability testing via light scattering and µ-DSC.
• Parameters assessed include Tonset, Tm, and Tagg to inform formulation and stability decisions.
• Supports both development-stage and regulatory stability studies.

Method Development, Qualification, and ICH Q2(R1) Compliance

• Bespoke method development tailored to peptide physicochemical profiles (hydrophobicity, charge, solubility).
• Method qualification in accordance with ICH Q2(R1) and internal SOPs.
• Generation of qualification reports and documentation suitable for comparability packages and regulatory submissions.
• SOPs and audit-ready documentation include raw data and analysis workflows for traceability.

Laboratory Instrumentation and Sample Formats

• SV-AUC: Optima Analytical Ultracentrifuge for high-resolution, high-throughput studies.
• DLS/SLS: DynaPro® Plate Reader III for simultaneous particle sizing and molecular weight determination in well-plate formats (sample volumes down to 4 µL).
• Zeta-potential: Malvern Zetasizer Lab for electrophoretic mobility measurements in cuvette format.
• Other platforms: SEC-MALS, AF4-MALS, and µ-DSC for peptide characterisation.

Partner with ZentriForce Pharma

By combining SV-AUC, DLS/SLS, SEC-MALLS, AF4, µ-DSC, and fractionation workflows, ZentriForce Pharma delivers a comprehensive suite of peptide drug analysis services. Whether supporting biosimilarity packages, formulation development, or regulatory submissions, the company provides reproducible, regulatory-ready data tailored to client needs.

📩 Contact ZentriForce Pharma today to discuss how the company’s peptide analysis services can support your development, biosimilarity, or regulatory project. Please email info@zentriforce.com or complete the Quick Contact Form.