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Analytics of Biologics

Due to their high complexity and potential variability in production, the analysis of biologics requires special methods and technologies.

Quality control at the highest level

Biologics are therapeutics and prophylactics whose active ingredients are derived from living cells, tissues, or organisms, characterized by their complex, high-molecular-weight structures and shaping the future of medicine. Unlike chemically synthesized drugs, biologics are typically manufactured using advanced biotechnology processes, including cell culture, fermentation, and recombinant DNA technology. This category encompasses a wide array of products such as monoclonal antibodies, recombinant proteins, vaccines, gene therapies, and allergenic extracts.

Biologics and its subunit Biopharmaceuticals include a diverse set of therapeutic products with unique structures, mechanisms of action, and clinical applications. Due to their molecular complexity and sensitivity to manufacturing variations, they require stringent controls throughout development and production to ensure batch consistency, quality, and regulatory compliance. They are reliant on biological systems for production and are characterized by their highly specific mechanisms of action within the body. See also our blog: Analytics of Biologics.

 

Our range of analytical services

Each class of biologic or biopharmaceutical presents unique analytical challenges. Advanced techniques such as LC-MS, CE, SEC-HPLC and bioactivity assays are essential to meet regulatory standards and ensure quality, safety, and efficacy across development and production stages. These tailored analytical approaches underscore the critical role of thorough characterization and quality control in biologics and biopharmaceuticals development.

Classes of Biologics and Biophramaceuticals

We provide comprehensive analytical services for the following product categories:

Monoclonal
Antibodies (mAbs)

Monoclonal antibodies (mAbs) are engineered to target specific antigens. Due to their structural complexity and modifications such as glycosylation, they require detailed analysis.

Monoclonal Antibodies (mAbs)

  • Identity Testing
    Confirm molecular weight, amino acid sequence, structural integrity, and PTMs of the antibody. Techniques: LC-MS, Capillary electrophoresis (CE)
  • Purity and Impurities
    To separate and quantify mAb fragments, impurities or aggregates. Techniques: LC-MS, SEC, CE, cIEF, Protein electrophoresis
  • Potency Testing
    Binding assays to measures the mAb’s ability to bind its target antigen. Techniques: ELISA
  • Glycan Profiling
    To analyse glycans released from the mAb. Techniques: LC-MS, HPLC, CE
  • Subvisible Particle Analysis
    To detect and quantify subvisible particles and aggregates to ensure quality and stability. Techniques: Laser Particle Counter
  • Stability Testing
    to evaluate degradation pathways under stress conditions (e.g., temperature, pH, agitation) by monitoring purity, potency, and other attributes over time. Techniques: SEC, CE-SDS, LC-MS, and UV-VIS spectrophotometry
  • Charge heterogeneity
    arises due to post-translational modifications (e.g., deamidation, glycosylation, oxidation) or variations in isoelectric point (pI). Detecting and characterizing these charge variants is crucial for ensuring the quality, stability, and efficacy of therapeutic antibodies. Techniques: cIEF, IEX, LC-MS
  • Disulfide bond mapping
    Disulfide bridges (S-S bonds) are crucial for the structural stability and function of antibodies. Proper characterization ensures correct folding, stability, and biological activity. Identifying disulfide bonds and detecting mispairing or scrambling is essential for therapeutic antibody development. Techniques: LC-MS, Protein electrophoresis

Biosimilars

Biosimilars are biologics developed to be highly similar to approved reference biologics. They require rigorous comparative analytics to demonstrate structural and functional similarity.

Biosimilars

  • Structural Characterization
    Verify the primary, secondary, tertiary, and quaternary structures to confirm similarity to the reference biologic. Techniques: Capillary electrophoresis (CE), SEC, LC-MS
  • Identity Testing
    Confirm molecular weight, amino acid sequence, structural integrity, and PTMs of the antibody. Techniques: LC-MS, CE
  • Glycan Profiling
    To analyse glycans released from the Biosimilar. Techniques: LC-MS, HPLC
  • Comparability Assessment
    To ensure overall comparability across multiple attributes, confirming that the biosimilar matches the reference biologic in a holistic manner.
    Comparative Analytical Studies: to integrate results from structure, purity, impurity, PTM, potency, and stability analyses to form a comprehensive comparability profile.
    Statistical Analysis: to evaluates biosimilar and reference product results to confirm that observed differences are within acceptable limits of similarity.
  • Immunogenicity Assessment
    To assess the potential for an immune response, as fusion proteins can present novel epitopes that may trigger immunogenicity. Techniques: ELISA/Anti-Drug Antibody (ADA) Assays, Epitope Mapping (LC-MS)
  • Functional Activity and Potency
    To demonstrate that the biosimilar’s biological activity is comparable to the reference biologic. Techniques: LC-MS, HPLC-UV, UV-Visible Spectroscopy, Fluorescence Spectroscopy
  • Purity and Impurities
    To identify and quantify impurities, including aggregates, fragments, and host cell proteins, to ensure product purity.Techniques: LC-MS, SEC, CE, cIEF, Protein electrophoresis
  • Stability Testing
    To evaluate degradation pathways under stress conditions (e.g., temperature, pH, agitation) by monitoring purity, potency, and other attributes over time. Techniques: SEC, CE-SDS, LC-MS, and UV-VIS spectrophotometry

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Recombinant Proteins

Recombinant proteins, including enzymes, growth factors, and hormones, are produced via genetic engineering. Their characterization requires confirmation of amino acid sequence, PTM profiling, purity, and stability.

Recombinant Proteins

  • Identity Testing
    Confirm molecular weight, amino acid sequence, structural integrity, and PTMs of the recombinant protein.Techniques: LC-MS, capillary electrophoresis (CE)
  • Purity and Impurities
    To separate and quantify fragments, impurities or aggregates. Techniques: LC-MS, SEC, CE, cIEF, protein electrophoresis
  • Stability Testing
    To assess degradation pathways and monitor structural or functional changes over time with or without application of stress conditions. Techniques: SEC, CE, protein electrophoresis, LC-MS, HPLC
  • Bioactivity assays for functional integrity
    Enzyme Activity Assays: To ensure proper enzymatic activity, if product has any. Techniques: LC-MS, HPLC-UV, UV-Visible Spectroscopy, Fluorescence Spectroscopy
    Binding and Interaction Assays: ELISA-based Binding Assays to measure binding between the recombinant protein and specific antibodies, receptors, or ligands immobilized on a plate, with detection typically through enzymatic or fluorescent signals Techniques: ELISA
    Receptor Activation Assays: Phosphorylation Assays, to quantify receptor phosphorylation, to confirm signalling pathway activation by the recombinant protein.Techniques: ELISA, LC-MS
  • Process-related impurity monitoring
     Including host cell proteins (HCPs) and residual DNA. Techniques: (ELISA, MS-based Proteomics, CE, HPLC, SEC, Protein electrophoresis)
  • Subvisible Particle Analysis
    To detect and quantify subvisible particles and aggregates to ensure quality and stability.Techniques: Laser Particle Counter

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Fusion Proteins

Fusion proteins are engineered biologics that combine two or more protein domains with distinct biological functions into a single molecule to achieve specific therapeutic functions.

Fusion Proteins

  • Structural Characterization
    To confirm the primary sequence and higher-order structures to ensure the fusion protein is correctly formed. For example PTM analysis, Glycan analysis, sequence validation, detection of aggregation and/or oligomerization. Techniques: Capillary electrophoresis (CE), SEC, LC-MS
  • Purity and Impurity Testing
    To identify and quantify impurities, including aggregates, fragments, and host cell proteins, to ensure product purity. Techniques: LC-MS, HPLC, SEC, CE, protein electrophoresis, ELISA.
  • Domain-Specific Analysis
    To confirm structural and functional consistency, particularly in response to changes in manufacturing processes or formulation. Techniques: Domain-Specific Binding and Functional Assays, (ELISA); Enzymatic Activity, (Fluorometric or Colorimetric Assays)
  • Comparability Studies
    Aassessments against a reference product ensure overall and domain-specific similarity.Physicochemical, functional and stability comparability.Techniques : SEC-HPLC, RP-HPLC, LC-MS, protein electrophoresis, CE-SDS, cIEF
  • Immunogenicity Assessment
    To assess the potential for an immune response, as fusion proteins can present novel epitopes that may trigger immunogenicity.    Techniques: ELISA/Anti-Drug Antibody (ADA) Assays, Epitope Mapping (LC-MS)

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Conjugated Biologics

Conjugated biologics, such as antibody-drug conjugates (ADCs), oligonucleotide conjugates, or protein conjugates, combine biologics with active substances such as cytotoxic agents for targeted therapy.

Conjugated Biologics (e.g., Antibody-Drug Conjugates, ADCs)

  • Characterization of Conjugation and Drug Loading
    Ensure consistent drug-to-antibody ratio (DAR), conjugation site specificity, and stability, which directly impact efficacy, pharmacokinetics, and safety. Techniques : HPLCS, LC-MS, UV-Vis Spectroscopy, Peptide Mapping LC-MS.
  • Purity and Impurity Testing
    To identify and quantify impurities, including aggregates, fragments, and host cell proteins, to ensure product purity. Techniques: LC-MS, HPLC, SEC, capillary eletrophoresis (CE), protein electrophoresis, ELISA.
  • Free drug content/Linker stability
    To identify and quantify impurities, including aggregates, fragments, and host cell proteins, to ensure product purity. Techniques : HPLC, UV-Vis Spectroscopy, CE, LC-MS
  • Structural Characterisation
    To determine the molecular weight, the location of the conjugation sites, and any modifications, to confirm its identity and integrity and to confirm the structure of the conjugated biologic. Techniques : LC-MS
  • Stability and Aggregation Studies
    To assess the physical and chemical stability of the biologic and monitor aggregation, degradation, or loss of the conjugated payload over time under various storage and stress conditions. Techniques: SEC, CE, LC-MS, fluorescence spectroscopy
  • Potency and Functional Activity
    To assess the ability of the conjugated biologics to bind to its target with the intended specificity and affinity and asses if they maintain activity after conjugation of payloads. Techniques: ELISA.

Peptide Therapeutics

Peptide-based biologics are hormones and synthetic peptides designed for specific biological activities, often mimicking natural signalling molecules.

Peptide Therapeutics

  • Identity and Sequence Confirmation
    To verify that the amino acid sequence matches the intended therapeutic design. Techniques: LC-MS, Amino Acid Analysis (AAA)
  • Structural Characterization
    To Confirm the peptide’s secondary and tertiary structures. Techniques: Circular Dichroism (CD) Spectroscopy
  • Post-Translational Modifications (PTMs) and Chemical Modifications
    To characterize PTMs or chemical modifications (e.g., phosphorylation, glycosylation, or lipidation) that can impact peptide stability, efficacy, or delivery. Techniques: LC-MS
  • Stability and Degradation Analysis
    To assess peptide stability under physiological as well as stress conditions, as peptides are prone to enzymatic degradation and chemical instability. Techniques: HPLC, LC-MS, capillary eletrophoresis (CE), UV-Vis Spectroscopy.
  • Immunogenicity Assessment
    To evaluate the potential for immune responses, as some peptides can be immunogenic depending on their sequence and modifications. Techniques: ELISA/Anti-Drug Antibody (ADA) Assays detecting antibodies against the therapeutic peptide, Cytokine Release Assays (ELISA), LC-MS
  • Purity and Impurity Testing
    To identify and quantify impurities, including aggregates, fragments, to ensure product purity. Techniques: LC-MS, HPLC, SEC, CE, ELISA.
  • Pharmacokinetics and Biodistribution
    To characterise the pharmacokinetic profile and tissue distribution, as peptides are often rapidly metabolized in vivo. Techniques: LC-MS, ELISA

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Competent analysis using state-of-the-art technology

In biologics development, achieving consistent quality and regulatory compliance hinges on precise, high-resolution analytical capabilities tailored for the complexity of these high-molecule therapeutics. Our range of analytical services integrates advanced, high-sensitivity techniques essential for the detailed characterization and quality control of biologics, ensuring the rigorous standards of accuracy, reproducibility, and traceability required throughout the product lifecycle.

With our state-of-the-art technology and dedicated expertise, we provide robust solutions for molecular identity verification, impurity profiling, structural analysis, and bioactivity assessment, all critical for maintaining the integrity, efficacy, and safety of biologic products.

 

 

Our technology platform

Liquid chromatography-mass spectrometry ( (LC-MS)

Our liquid chromatography-mass spectrometry (LC-MS) platform is an essential cornerstone of our quality control capabilities. We offer ultra-performance liquid chromatography (UPLC) coupled with a range of mass spectrometers, including triple quadrupole and high-resolution quadrupole time-of-flight (QTOF) instruments like the ZenoTOF 6700.

This suite allows for precise molecular weight determination, in-depth post-translational modification (PTM) analysis, and quantification of both major and minor variants, enabling us to thoroughly characterize complex biologics and monitor critical quality attributes (CQAs) with exceptional resolution and sensitivity. High-quality data from these instruments supports identity confirmation, impurity quantification, and stability assessments, all essential for regulatory submissions and product consistency.

Capillary electrophoresis (CE) and on-chip electrophoresis

Beyond MS, our capillary electrophoresis (CE) and on-chip electrophoresis (Bioanalyzer) systems offer high-resolution separations critical for purity assessments and the detection of charge variants, isoforms, and glycoforms. These methods ensure comprehensive profiling and consistency between batches, a key component of regulatory quality control, particularly for complex protein and glycoprotein therapeutics.

Our electrophoresis techniques are validated for reliability and reproducibility, ensuring that each batch meets strict quality thresholds and mitigates the risk of immunogenicity associated with structural heterogeneity.

High-performance liquid chromatography (HPLC and UPLC)

Our high-performance liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) systems further expand our quality control toolkit with robust separation and detection options, including photodiode array (PDA) and charged aerosol detectors (CAD). These detectors enhance our ability to monitor impurities, degradants, and other process-related contaminants, ensuring product safety and compliance with regulatory standards.

HPLC and UPLC methods are critical in impurity profiling, stability studies, and quantitative assays, providing comprehensive data that supports release testing, stability testing, and in-process monitoring.

Gas chromatography-mass spectrometry (GC-MS)

Our gas chromatography-mass spectrometry (GC-MS) system is a complementary component of our biologics analytical capabilities, enabling precise analysis of volatile and semi-volatile compounds. By integrating advanced gas chromatographic separation with high-sensitivity mass spectrometric detection, this technology provides unparalleled resolution and specificity for the identification and quantification of small molecule impurities, residual solvents, and volatile degradation products.

GC-MS plays a crucial role in impurity profiling, residual solvent analysis, lipid analysis (lipid-based delivery systems), metabolite monitoring and the analysis of excipients in biologic formulations, ensuring compliance with stringent regulatory standards. This analytical technique further enhances our ability to monitor critical quality attributes (CQAs), ensuring product safety, stability, and efficacy.

Microplate reader with UV-Vis and fluorescence detection

Our microplate reader with UV-Vis and fluorescence detection is integral to biologics analysis, enabling precise evaluation of quality attributes such as protein concentration, enzymatic activity, and molecular interactions. This technology supports a wide range of assays, including Bradford and BCA for protein quantification, enzyme kinetics using substrate conversion assays, and fluorescence-based ligand-binding studies.

Its versatility extends to applications like stability testing, potency assays, and high-throughput screening, delivering reliable data essential for product characterization, batch release, and regulatory compliance.

More Services

In addition to other laboratory services , we also offer drug development, the production of small batches and GxP services. If you have any questions or would like a personal consultation, please do not hesitate to contact us.

Contact us. We’re happy to help!

Dr. Sandra Hürtgen
Analytical Development

Phone: +49 7272 7767-2571
Email:

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

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Q&A

What type of pharmaceuticals are called biologics?

Biologics or biopharmaceuticals are therapeutic drugs or vaccines whose active ingredients or antigens are produced using genetically modified organisms. In contrast to chemically synthesized drugs, biologicals are often complex, large molecules. Typical examples are monoclonal antibodies, recombinant proteins and nucleic acid preparations, for example in modern vaccine preparations. These biological molecules are often produced in cell lines using recombinant DNA technologies. Organisms such as bacteria, yeasts or mammalian cells are used for this purpose.

What are biosimilars?

Biosimilars are imitation products of biologics that are no longer subject to patent protection. In contrast to generics, biosimilars are as similar as possible to the original preparation but not identical to it.

Why is the analysis of biologics an important topic?

Global sales of biologics reached around USD 402 billion in 2023 and are expected to rise to USD 749 billion by 2030 (Coherent Market Insights - Biologics Market). In Germany, biologics accounted for almost 35% of the total biopharmaceuticals market in 2023, and the trend is rising. This market is driven by the high demand for biological therapies, especially for chronic diseases such as cancer and autoimmune diseases. Monoclonal antibodies in particular are a leading segment, as they can specifically combat diseases such as cancer.

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