Biosimilar analysis
Detailed analysis of biosimilars and comparison to originator
MoreLess details
- Front page
- »
- Biosimilar analysis
Our services
Our experts in protein analysis by mass spectrometry can help you in the following areas:
Start the collaboration
We offer customized solutions, contact us to discuss your project.
Ask a question or get a quote
Send us a description of your project and we shall be happy to present you with a solution.
Set up a phone meeting
We encourage you to call us or schedule a meeting to discuss your project in detail.
Set up meetingMore info
When producing a biosimilar – a generic version of an original biotherapeutic reference product (innovator) – both biological potency, safety, and efficacy must be assessed during the characterization process. This is especially important for quality assurance purposes and to obtain approval from regulatory agencies like FDA and EMA.
The above services can be utilized for e.g. non-GLP exploratory studies, pre-clinical, and clinical development processes. They also serve as tools for various purification steps, including to remove process-related impurities. With top-of-the-line instruments, PhD-level scientists and the latest industry knowledge of protein analysis, biosimilar analytical comparability is in place for all analyses.
Chromatography and mass spectrometry are combined as the center of our analytics, which ensures high reproducibility and high throughput. The analyses can be applied to all types of biosimilar products, where the active pharmaceutical ingredient (API) is protein. Examples include monoclonal antibodies, Fc-fusion proteins, interleukins and other cytokines, and recombinant proteins like insulin and erythropoietin.
Who is this for?
We primarily help customers within the pharmaceutical industry, and biotechs working on drug development, e.g.
Project managers
Working with process development and characterization projects.
Experts
Protein scientists that work with elisa, masss spectrometry, or CMC.