Surfactant Characterization

Our Services
Surfactant Characterization
Aggregate Analytics Particle Characterization Particle Identification Higher-Order Structure Analysis Functional Assays Chemical Change Analysis Lyophilizate Analytical Services Container Closure and Integrity Testing Basic Formulation Characterization Stability Testing Release Testing

Coriolis Pharma offers cutting-edge surfactant analytics services to ensure the quality, stability and efficacy of your biopharmaceutical products. Leveraging our scientific expertise and advanced technologies, we provide comprehensive surfactant characterization that supports formulation development, stability studies and regulatory compliance requirements.

Surfactant Characterization from the Scientific Experts

Surfactants are crucial in stabilizing biomolecules against interfacial stress and preventing adsorption. Polysorbate 20, polysorbate 80 and poloxamer 188 are the only surfactants in FDA-approved drug products for biopharmaceutical parenteral applications. While these surfactants offer significant benefits, it’s widely recognized that they, particularly polysorbates, are susceptible to degradation through hydrolysis and oxidation. (Poloxamer is highly sensitive to oxidation.) This degradation can directly impact the surfactant’s function and potentially lead to the formation of insoluble fatty acid–related particles over time, posing potential risks to the safety and efficacy of biopharmaceutical drug products.

Coriolis offers in-depth characterization of surfactants to address these challenges throughout the drug development process.

Our expert scientists analyze various aspects of surfactant formulations, including:

  • Quantification of surfactant concentration
  • Characterization of surfactant composition and purity
  • Identification and quantification of degradation products
  • Analysis of fatty acids
  • Detection of impurities and particles

We can take samples at various stages of product development to test surfactant characteristics and obtain data for stability studies.

Surfactant Characterization Tailored to Your Needs

Our analytics are tailored to meet specific quality requirements for surfactants. Pharmacopeias around the world specify specific requirements for pharmaceutical-grade polysorbate 20 and 80. For example, ICH countries agree on key requirements such as impurity levels and fatty acid composition.

Coriolis has developed strong expertise and analytical capabilities for surfactant characterization, particularly for quantifying and characterizing polysorbates, poloxamers and their degradation products. We recognize the challenges in analyzing these structurally heterogeneous compounds, which often lack chromophores. To address this, we employ a range of sophisticated techniques, including derivatization with dyes and the use of universal detectors such as charged aerosol detection (CAD) or mass spectrometry (MS) in combination with liquid chromatography (LC).

We develop suitable sample preparation procedures for protein removal for chromatography-based methods, such as organic solvent precipitation or isolate surfactants using solid-phase extraction (SPE). These tailored approaches ensure accurate and comprehensive analysis of your surfactant-containing formulations. We have developed a novel two-dimensional liquid chromatography (2D-LC) approach that allows online sample preparation for protein removal and analysis of the surfactant in less than 10 minutes (for mAbs).

Our surfactant characterization services are performed under R&D and GMP conditions in dedicated labs with complete quality oversight. These services can also be applied to viruses, cells and viral vectors, and fall under biosafety level 2.

Surfactant Characterization Testing Methods

We will select the most suitable approach for your analytical challenge, whether following a standardized in-house workflow or a custom-tailored solution.

Liquid chromatography with charged aerosol detection (LC-CAD) Liquid chromatography coupled mass spectrometry (LC-MS)

Surfactant Characterization Frequently Asked Questions (FAQs)

  • Surfactant characterization involves analyzing surfactant content, composition, degradation products, and impurities in biopharmaceutical formulations. This ensures drug product stability, efficacy, and safety throughout development and shelf life.

  • Polysorbates are commonly used surfactants in biologic drug products, but they are prone to degradation by hydrolysis and oxidation. Analyzing their concentration and breakdown products helps prevent particle formation and maintain product stability.

  • Coriolis uses advanced analytical techniques such as LC-CAD, LC-MS, and 2D-LC to identify and quantify degradation products and impurities. These methods enable rapid and accurate monitoring of oxidative and hydrolytic degradation pathways.

  • Surfactants are structurally heterogeneous and often lack chromophores, making detection difficult. Coriolis addresses this with specialized sample prep techniques and detectors like CAD and mass spectrometry to ensure sensitive and specific results.

  • Yes. Surfactant analysis is an essential part of stability testing. It helps assess the impact of storage conditions and shelf life on surfactant performance, contributing to risk assessment and regulatory compliance.

  • Pharmacopeias such as USP and Ph. Eur. specify requirements for polysorbate quality, including fatty acid composition and impurity levels. Coriolis ensures analytical methods align with ICH guidelines and GMP expectations.

  • Yes. Surfactant characterization services at Coriolis are available under both R&D and GMP conditions, performed in dedicated labs with full quality oversight.

  • Coriolis can analyze surfactants in biologics, including monoclonal antibodies (mAbs), viral vectors, vaccines, and other drug products. The lab supports biosafety level 2 handling for complex and sensitive formulations.

  • For monoclonal antibodies, the novel 2D-LC method developed by Coriolis enables online sample prep and surfactant quantification in under 10 minutes, increasing throughput and reducing turnaround time.

  • Poloxamer 188 is a nonionic surfactant used in biologics, especially sensitive to oxidation. Coriolis applies specialized methods like LC-MS to evaluate its integrity and identify degradation products.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

We’ve worked with over 930 modalities, and the number is growing by the day.

Your Drug Product

Coriolis Pharma’s deep expertise across many biologic modalities, combined with input from world-leading external advisors, offers the knowledge and experience needed to solve even the most complex formulation and drug development challenges.

Antibody or Related Product
Peptide
Therapeutic Protein
Gene & Cell Therapy
Viral Vector
Nucleic Acid
Vaccine
Nanoparticulate Delivery Systems

Your Phase

Our expert team has the expertise and experience to guide your biologics formulation development program from preclinical and early-phase development to the market.

Coriolis Effect

See how our expertise and comprehensive services accelerate biologics development from preclinical to the market.

Surfactant Characterization Resources

Physicochemical Comparison of Kolliphor HS 15, ELP, and Conventional Surfactants for Antibody Stabilization in Biopharmaceutical Formulations

Publications

Physicochemical Comparison of Kolliphor HS 15, ELP, and Conventional Surfactants for Antibody Stabilization in Biopharmaceutical Formulations

July 10, 2025

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Additivity of Transfer Free Energies Enables the Description of Complex Protein Formulations in Implicit Solvent Molecular Dynamics Simulations

Publications

Additivity of Transfer Free Energies Enables the Description of Complex Protein Formulations in Implicit Solvent Molecular Dynamics Simulations

June 6, 2025

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The Science Behind Surfactant Stability: How Experts at Coriolis Pharma Analyze and Control Degradation?

Articles

The Science Behind Surfactant Stability: How Experts at Coriolis Pharma Analyze and Control Degradation?

May 19, 2025

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Direct comparison of single peak and gradient chromatographic methods for routine analysis of surfactants in biopharmaceuticals

Publications

Direct comparison of single peak and gradient chromatographic methods for routine analysis of surfactants in biopharmaceuticals

March 27, 2025

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