Biological activity of biopharmaceutical compounds

We study the biological activity of your biopharmaceutical compound

Biological activity is, besides the safety of the therapy, the most important aspect of a drug product or therapy. Thus, a major goal of formulation development is to maintain the functionality of the therapeutic compound inside its formulation throughout its shelf-life.

Functional assays by the analytical expert

Coriolis offers a range of different functional assay types. In a unique collaborative approach, our analytical experts develop tailored methods for your application, including:

  • Antibody binding affinity and specificity
  • Infectivity and titer determination for viruses and viral vectors
  • Ligand-receptor binding

Functional assays specific for your drug substance and product type

We offer functional assays for the following product types. This service is based on our broad scientific experience with a large variety of biopharmaceutical samples. We will tailor each assay 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.


Method development

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.


Method qualification

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.


Method validation

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.

Analytical Methods

Analytical Methods

Enzyme-linked immunosorbent assay (ELISA)
Cell-Based Assay (Activity, Infectivity, Binding)
Quantitative polymerase chain reaction (qPCR)


Webinars and Publications

Webinars and Publications

Contact us

Contact us

For enquiries related to functional assays please contact Dr. Jörg Müller

Dr, Jörg Müller