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
  • 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)

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 more than 930 compounds, and that 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

Factors Influencing Polysorbate’s Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Publications

Factors Influencing Polysorbate’s Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

January 1, 2019

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Does Controlled Nucleation Impact the Properties and Stability of Lyophilized Monoclonal Antibody Formulations?

Publications

Does Controlled Nucleation Impact the Properties and Stability of Lyophilized Monoclonal Antibody Formulations?

August 1, 2018

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Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

Publications

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations

July 1, 2017

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IgG1 Adsorption to Siliconized Glass Vials-Influence of pH, Ionic Strength, and Nonionic Surfactants

Publications

IgG1 Adsorption to Siliconized Glass Vials-Influence of pH, Ionic Strength, and Nonionic Surfactants

November 1, 2014

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Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

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