Analytical services for surfactant quantifiation and characterization
Surfactants stabilize biomolecules against interfacial stress and/or prevent adsorption. Polysorbate 20, polysorbate 80 and poloxamer 188 are so far the only FDA-approved surfactants for parenteral application in biopharmaceutical products.
Besides their benefits, it is common knowledge that surfactants, such as polysorbates, are prone to degradation by hydrolysis and oxidation. While such degradation can directly affect the function of the surfactant, it could also lead to the formation of insoluble fatty acid-related particles over time - a potential issue for the safety and efficacy of a biopharmaceutical drug product.
Quality requirements for surfactants
The quality requirements for pharmaceutical grade polysorbate 20 and 80 are specified in the different pharmacopoeias. Further, the ICH countries agree on the key requirements, such as impurity levels and fatty acid composition. For polysorbate 80, the Chinese Pharmacopoeia describes the strictest regulations for the fatty acid composition and requests an all-oleate polysorbate (≥ 98%), whereas the European and US pharmacopoeias specify a purity of ≥ 58% for oleic acid.
Surfactant characterization from the scientific expert
Multicompendial surfactants complying to all current pharmacopoeias are available. However, their analytical characterization is very challenging due to the structural heterogeneity, the presence of degradants and other impurities. Coriolis has built up strong expertise and analytical capabilities for surfactant characterization, in particular for the quantification and characterization of polysorbates, poloxamers and their degradation products.
Due to the lack of chromophores, we either derivatize polysorbate with dyes or use universal detectors such as charged aerosol detectors (CAD) or mass spectrometry (MS) in combination with liquid chromatography (LC). For the chromatography-based methods, we develop suitable sample preparation procedures for protein removal e.g., by organic solvent precipitation, or to isolate surfactant by using solid phase extraction (SPE).
Surfactant characterization tailored to your drug product
We offer the surfactant characterization based on our broad scientific experience with a large variety of biopharmaceutical samples. We will tailor each project to your specific product type, development phase and material availabilities. Click on a product type to explore our entire portfolio of specialized analytical as well as research and development services.
Quality & biosafety level of this service
We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:
From generic to custom analytical methods and beyond
We offer a large selection of generic analytical methods for many common applications or develop custom methods specific for your needs. Our expert scientists also perform a method feasibility to assess, which technique is most suitable for your request. We offer the following options:
Methods ready to use
Our expert scientists have established generic analytical methods for many common applications. This guarantees a quick turnaround for sample testing and reduces the need for method adjustments to a minimum.
We suggest generic methods for your sample based on our many years of experience with similar products and analytical questions. If you reach a development stage, where fully developed and documented methods are required, we can build upon our expertise in customizing and optimizing any analytical method.
During method development, we tailor sample preparation, method settings, and data analysis to the needs of your project and sample.
For this purpose, we include a representative sample and, where available, suitable reference standards and stressed/degraded materials. This way, our analytical scientists can design a method that is highly suitable for your needs, stability indicating, as well as robust and repeatable. Upon request, we compile a detailed method description for your records.
A method qualification is the initial assessment of the performance of an analytical procedure to show that it is suitable for the intended purpose.
During method qualification, our analytical scientists perform documented testing to establish and assess acceptance criteria in several performance characteristics. These may include repeatability, linearity, intermediate precision, robustness and more. We compile a qualification plan and a qualification report including all relevant data.
A method validation is the confirmation under highly controlled conditions that the performance of an analytical procedure is suitable for the intended purpose.
During method validation, our analytical scientists perform a documented testing, which demonstrates that the analytical procedure consistently produces a result that meets pre-determined acceptance criteria. We compile a validation plan and a validation report including all relevant data.
Our know-how related to surfactant characterization
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.