Biologics and Biosimilars

The Biopharmaceutical Analyses Department provides comprehensive analytical services to support the development, characterisation, and quality control of biologics and biosimilars. Our expertise covers a wide spectrum of molecules, including peptides, monoclonal antibodies, fusion proteins, and antibody–drug conjugates (ADCs).

We deliver post-production characterisation, potency assessment, quantification of biopharmaceuticals in biological matrices, immunogenicity testing, pharmacokinetic (PK) and statistical data analysis, and plasma protein binding studies. PK sample analysis is performed with high precision using either liquid chromatography–mass spectrometry (LC-MS) or ligand-binding assays (LBAs), depending on the molecule and required sensitivity.

All services are performed in full compliance with EMA, FDA, and ICH guidelines, ensuring scientifically robust and regulatory-compliant results that help bring safe and effective biopharmaceutical products to market.

Biologics and biosimilars

Equipment

Our state-of-the-art department is equipped with a diverse range of advanced analytical instruments and technologies to support comprehensive biologics analysis. This broad arsenal allows us to test every stage of biologic development accurately and efficiently — from starting materials to drug substances, intermediates, and final products.

SoloVPE: Rapid, accurate measurement of protein concentration and purity using advanced absorbance technology.
Maurice System: Capillary electrophoresis platform for high-resolution separation and characterization of proteins and peptides.
Capillary Electrophoresis: Precise separation of biomolecules based on size and charge, ideal for purity, isoform distribution, and glycosylation profiling.
Gel Electrophoresis (SDS-PAGE): Robust method for assessing protein purity, molecular weight, and potential aggregation.
Isoelectric Focusing (IEF/cIEF): High-resolution technique for analyzing protein charge heterogeneity and confirming isoelectric points.
Automatic Amino Acid Analysis: Quantitative profiling of amino acid composition to confirm protein identity and structural integrity.
LC-FTMS (Liquid Chromatography–Fourier Transform Mass Spectrometry): Provides ultra‑high‑resolution and accurate mass measurements, enabling detailed structural elucidation and precise characterization of biologics, even in complex matrices.
UHPLC-MS/MS (QqQ and ion trap): Powerful tool for sensitive and specific quantification and characterization of peptides, proteins, and metabolites.
ELISA (Enzyme-Linked Immunosorbent Assay): Sensitive and specific quantification of proteins, antibodies, and biomarkers in complex biological samples.
ECLA (Electrochemiluminescence Assay): Highly sensitive detection for immunogenicity and bioanalytical applications, offering broad dynamic range and precision.
Cell-Based Assays: Functional testing of biologics to assess potency, efficacy, and immunogenicity in relevant biological models.

Post-production Characterization

We provide comprehensive post-production characterization of protein therapeutics following ICH Q6B guidelines. Using advanced, reliable methodologies, we ensure that only biologics of the highest quality advance through your development pipeline, helping you move forward with confidence and regulatory compliance.

Our thorough approach covers:

Structural Confirmation: Verifying primary sequence, terminal ends, and disulfide bonds to ensure identity and correct folding.
Physicochemical Profiling: Measuring molecular weight, charge variants, isoelectric point, and other key properties to maintain purity and batch consistency.
Post-Translational Modifications (PTMs): Detecting critical changes such as glycosylation and oxidation affecting function.
Purity and Impurity Assessment: Identifying aggregates, residual nucleic acids, host cell proteins, and endotoxins—impurities that, if above acceptable limits, may trigger severe immune reactions.
Biological Activity Testing: Validating potency and function through targeted bioassays and cell-based assays.
Immunochemical Properties: Assessing antibody specificity and immune-related activity.
Batch Consistency and Comparability: Confirming homogeneity and quality across production lots.

Adhering to ICH Q6B recommendations, we thoroughly characterize proteins and peptides by appearance, molecular weight, isoelectric point, pH, amino acid content, primary structure, and disulfide bridge positions. Rigorous purity analysis is critical, as elevated levels of aggregates, nucleic acids, or endotoxins may provoke adverse immune reactions.

Potency Assessment

Consistent potency is critical to the success of every biologic therapy. We ensure your biologics deliver the intended activity and clinical efficacy with validated potency testing fully aligned with international regulatory expectations, including ICH Q6B, ICH Q2(R2), FDA, and EMA guidelines.

Non-Cell-Based Potency Assays: Precise measurement of enzymatic activity, receptor binding, or ligand interactions tailored to your biologic’s mechanism of action.

Cell-Based Potency Assays: Functional evaluation of biological responses in relevant cell systems, capturing complex mechanisms such as signaling, neutralization, and cytotoxic effects.

All assays are developed and validated under strict regulatory standards for accuracy, precision, and robustness. The result: reliable, reproducible data to support lot release, stability, and comparability studies.

Quantification in Biological Matrices

Quantification of biopharmaceuticals in biological matrices is performed for pharmacokinetic (PK), toxicokinetic (TK), and bioavailability studies, providing data essential for dose selection, efficacy assessment, and regulatory submissions.

We apply ligand-binding assays (LBAs) such as ELISA, ECL, and SPR for high-sensitivity measurement of large molecules, and liquid chromatography–mass spectrometry (LC-MS) for high-specificity analysis of complex molecules such as antibody–drug conjugates (ADCs) or fusion proteins. Method choice depends on molecule type, target concentration range, and matrix complexity.

All methods are developed, transferred, and validated in full compliance with ICH M10 (Bioanalytical Method Validation), FDA Bioanalytical Method Validation Guidance (2018), and EMA Guideline on Bioanalytical Method Validation (2011). Our validated methods deliver reliable and reproducible results for both clinical and non-clinical studies, supporting confident decision-making throughout development.

Immunogenicity Testing

Immunogenicity testing is performed to detect and characterise anti-drug antibodies (ADAs) that may affect the safety, efficacy, or pharmacokinetics of biopharmaceutical products. These assessments are required during both clinical and non-clinical studies to meet regulatory expectations and manage patient risk.

We use a tiered approach in line with FDA (2019 Immunogenicity Testing of Therapeutic Protein Products), EMA (2017 Guideline on Immunogenicity Assessment of Therapeutic Proteins), and ICH S6(R1). Screening is carried out using sensitive ligand-binding assays (LBAs) such as ELISA or ECL. Confirmatory assays differentiate specific from non-specific binding, and titre assays quantify the immune response. For neutralising antibody (NAb) detection, we employ cell-based or competitive ligand-binding methods, selected according to the biopharmaceutical’s mechanism of action.

Pharmacokinetic and Statistical Data Analysis

Pharmacokinetic (PK) and statistical data analysis is essential for interpreting bioanalytical results and understanding the absorption, distribution, metabolism, and excretion of biopharmaceutical products. These analyses support dose selection, efficacy evaluation, and regulatory submissions.

Our team perform non-compartmental and compartmental PK analysis, bioequivalence (BE) evaluation, and statistical assessments in compliance with EMA and FDA guidelines. Using Phoenix WinNonlin®, the global gold standard for PK/PD modelling, we ensure that all analyses meet the highest scientific and regulatory standards.

Capabilities:

Non-compartmental analysis (NCA) for PK parameter estimation.
Compartmental modelling for complex PK profiles.
Bioequivalence and comparative PK assessments.
Statistical analysis for clinical and non-clinical studies, including ANOVA, mixed-effects models, and non-parametric tests.
Data handling and reporting in line with Good Clinical Practice (GCP) and regulatory standards.

Plasma Protein Binding

Plasma protein binding (PPB) studies determine the extent to which a biopharmaceutical binds to plasma proteins, which can significantly influence its distribution, clearance, and pharmacological activity.

We perform PPB studies using validated equilibrium dialysis, ultrafiltration, or ultracentrifugation methods, selected based on the physicochemical properties of the molecule. Analysis of bound and unbound fractions is carried out using ligand-binding assays (LBAs) or liquid chromatography–mass spectrometry (LC-MS), ensuring precise quantification.