Analytical Services for (Bio) Pharmaceuticals & ATMPs

ZentriForce Pharma offers a suite of biophysical analytical services to meet the complex demands of modern therapeutic development. From early-stage formulation through to advanced analytical characterization, ZentriForce provides comprehensive testing of BSL-1 and BSL-2 samples using state-of-the-art methodologies and technologies.

Biosimilar Studies

The focus is on demonstrating high similarity between biosimilar candidates and reference products by thoroughly characterizing critical quality attributes (CQAs) with scientific precision and regulatory clarity. This includes assessing molecular weight, higher-order structure, aggregation, and thermal stability, process- and product-related impurities, among other critical quality attributes.

Biopharmaceutical Development

The development of biopharmaceutical products is a complex and resource-intensive process. Specialized expertise in analytical method development and consultation plays a crucial role in supporting these efforts.

Key areas of support focus on analytical method development and validation, formulation development, characterization of critical quality attributes (CQAs), and stability studies. This includes designing and validating methods to assess product quality, developing stable formulations through buffer and excipient screening, and optimizing storage and handling conditions. Additional services encompass long-term and accelerated stability testing, forced degradation studies, and detailed analysis of aggregation and purity.

Further support is provided for lead candidate selection through comparative analytical assessment, as well as method qualification and validation according to ICH and regulatory standards to ensure reliable release and stability testing.

Advanced Analytics for Protein and Peptide Therapeutics

ZentriForce provides tailored support for the development of protein-based therapeutics, including monoclonal antibodies and peptide drugs. The company’s analytical services are designed to support development, optimisation, and comparability studies across product lifecycles, including impurity profiling, stability assessment, and method development using high-sensitivity instrumentation.

Gene Therapy Analytical Services

Characterisation of Viral and Non-Viral Vectors

Gene therapy development requires specialised analytical support to evaluate vector quality, potency, and safety. ZentriForce offers robust techniques for assessing viral particles, nucleic acid complexes, and lipid-based carriers.

Adeno-Associated Virus (AAV): Focused Analysis for a Leading Vector

AAVs are widely used in gene therapy due to their safety profile and manageable size. ZentriForce offers specific testing for AAV-based products, including:

• Accurate quantification of full-to-empty capsid ratios

• Particle size distribution and aggregation assessment

• Purity profiling to ensure batch consistency

Virus Product Development: Adapted Testing for Large Vectors

For larger or more complex viral vectors, analytical approaches are adapted to meet the unique characteristics of each product. Services focus on:

• Size and aggregation analysis

• Purity and heterogeneity profiling

• Support for consistent manufacturing and clinical safety

Emerging Gene Therapy Modalities: Flexible Solutions for Non-Viral Products

Supporting non-viral gene therapy formats such as lipid nanoparticles and nucleic acid complexes, ZentriForce provides:

• Method development and validation tailored to novel formulations

• Comprehensive characterization of biophysical properties

• Expert data interpretation to inform formulation and regulatory strategies

Analytical Techniques Overview: Tools for Molecular Insight

ZentriForce Pharma employs a versatile and robust portfolio of analytical methods designed to provide comprehensive characterization of complex biologics and biotherapeutics.

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC)

• Principle: Measures the sedimentation behavior of particles under high centrifugal force to determine size, shape, and heterogeneity in solution.

• Strengths: Gold standard for resolving complex mixtures and quantifying soluble aggregates without the need for separation matrices or columns.

• Applications: Aggregate quantification, monomer/oligomer distribution, viral vector characterization (e.g., full/empty capsid ratio), and protein-protein interactions.

Asymmetrical Flow Field-Flow Fractionation (AF4)

• Principle: Size-based separation using a flow field across a thin channel, enabling gentle fractionation of particles based on hydrodynamic radius.

• Strengths: Broad size range (1 nm to 1 µm), minimal shear stress preserving native conformations, compatibility with various detectors (MALS, UV, RI).

• Applications: Separation of heterogeneous mixtures, characterization of nanoparticles, liposomes, virus-like particles, and protein conjugates.

Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS)

• Principle: Chromatographic separation by size followed by absolute molar mass and size measurement using MALS detection.

• Strengths: Simultaneous determination of molecular weight and size, well-established and widely accepted by regulatory agencies.

• Applications: Protein aggregation, molecular weight distribution, antibody-drug conjugate (ADC) characterization, and PEGylated protein analysis.

Micro Differential Scanning Calorimetry (μ-DSC)

• Principle: Measures heat capacity changes as a function of temperature to monitor thermally induced transitions (e.g., unfolding, binding).

• Strengths: Label-free, highly sensitive, suitable for most buffers and solvents; no requirement for specific residues or dyes.

• Applications: Protein Stability, conformational analysis, binding studies, and delivery systems.

Dynamic Light Scattering (DLS)

• Principle: Measures fluctuations in scattered light intensity caused by Brownian motion to determine hydrodynamic diameter and size distribution.

• Strengths: Fast, non-destructive, requires minimal sample preparation, suited for high-throughput screening.

• Applications: Particle sizing in formulations, early detection of aggregation, stability studies, and buffer optimization.

Orthogonal Approach for Robust Characterization

By applying these complementary techniques in tandem, ZentriForce Pharma provides a multidimensional view of product quality and molecular behavior. This orthogonal strategy ensures data reliability, supports regulatory submissions, and aids decision-making throughout product development.