Orthogonal analysis of aggregates in biopharmaceutical samples with the latest technologies
Qualitative and quantitative data on aggregation is a key asset for assuring quality of biologics. Most protein therapeutics and many other biopharmaceutical compounds are inherently unstable and can undergo aggregation through various pathways. Aggregates of various kinds can be formed, such as reversible and non-reversible, soluble, and non-soluble etc. Aggregation can directly influence the efficacy of the therapy by reducing the number of functional molecules, but also indirectly influence efficacy as well as safety of a therapy by inducing side-effects, such as unwanted immunogenicity.
Coriolis offers a large portfolio of analytical techniques for the characterization and quantification of aggregates in biopharmaceutical samples. We apply orthogonal methods, e.g., size exclusion chromatography and analytical ultracentrifugation, whenever possible to circumvent any potential blind spots of individual techniques.
Quantification of aggregates in a wide size range
The generic term “aggregates” refers to species characterized by a wide size range, diverse morphologies and structures. Protein aggregates may start in the low nanometer size range but then can grow into the micrometer and even visible size range. On the other hand, a monomeric virus may be as large as 100 nm. Because of this structural diversity a tailored orthogonal approach is key in detecting and/or quantifying all the potential aggregates present in a biopharmaceutical.
Coriolis offers a multitude of orthogonal analytical techniques to cover the entire size range of interest for the different type of molecules and products.
Is it an aggregate or a particle?
The terms aggregate and particle are not used consistently in the scientific community and may differ depending on the biopharmaceutical in question. For example, a monomeric virus may be considered a virus particle, while a virus dimer may be considered an aggregate. Also, a protein aggregate may become large enough to be considered a particle. For species in the micrometer and visible size range, please also refer to our analytical services for particle characterization.
Aggregate analysis tailored to your drug product
With many years of experience in aggregates analysis across a variety of biopharmaceutical samples, we will tailor the approach to your specific product type, development phase and material availabilities. Click on a product type to explore our entire portfolio of specialized analytical 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:
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.This is available for a selection of analytical techniques.
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.This can be applied to all our techniques (R&D and GMP). Read more.
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.This can be applied to all our techniques (R&D and GMP). Read more.
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.This can only be applied to our techniques under GMP. Read more.
Our know-how related to aggregate analytics
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:
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for many research, development, and analytical challenges. Explore our 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.