Your ProfessionalContract Analysis Partner in biologics development

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New webinar
Cell and gene therapies: Ready for FDA questions about impurities?

In 30 minutes you get an overview of the documentation guidelines for
process related impurities in cell and gene therapies. You are also introduced
to a mass spectrometry method to monitor multiple proteins with one assay.

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Focus on
Coverage analysis of ELISA

Our new HCP coverage analysis based on immunocapture with ELISA polyclonal antibodies followed by LC-MS/MS protein identification is a breakthrough in evaluation of ELISA HCP coverage. The analysis is performed on the native HCP antigens and provides a list of individual HCPs recognized by the ELISA antibodies.

More about our coverage analysis

Focus on
HCP analysis

We offer a broad range of mass spectrometry based analyses of Host Cell Proteins that can be applied from the onset of your project and throughout the development phase. Apply the analysis on its own or in combination with ELISA assays for detailed analysis of process-related impurities in your biologic

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Focus on
GPMAW lite

GPMAW lite is a free protein bioinformatics tool with which you can perform basic calculations, like molar mass conversion. Use it on any protein amino acid sequence and get info about pI, MW and amino acid composition

Start GPMAW lite

In good company

For more than 15 years we have provided detailed protein
ms analysis service to customers all over the world. Among our customers you find both small and large scale biotech companies
and 8 of the top-10 pharmaceutical companies.

Professional protein analysis service for the biopharmaceutical industry

Since 2002 Alphalyse has provided standard and custom protein analysis services to the biopharmaceutical industry, biotech companies and universities worldwide. Over the years, we have serviced thousands of customers from our protein analysis lab and offices in Denmark and the USA.

Alphalyse is a contract research laboratory (CRO), proficient in protein chemistry, mass spectrometry and bioinformatics. Our team of dedicated and highly skilled protein scientists is committed to helping your bring your processes forward, by analyzing biopharmaceutical proteins using top-of-the-line equipment.

As a CRO, we have obtained a lot of knowledge over the years through our many customer projects

Frequently asked questions

Which analyses should be included in biopharmaceutical protein analysis?

For approval by regulatory authorities, typically methods like intact mass, peptide mapping, N-terminal sequencing and impurity analysis must be carried out to ensure proper documentation. This is both to verify the protein sequence, assess PTMs, evaluate the purity (and identify harmful protein residuals), as well as establish production consistency.

Where can I get more information about Host Cell Protein analysis by mass spectrometry?

A great place to start is a webinar. You can find on-demand webinars at https://www.alphalyse.com/webinars/

What makes Alphalyse experts in HCP analysis?

Since 2002 our protein analysis lab has conducted thousands of analysis projects. Our first article on the use of mass spectrometry was published in 2008. Since then we have developed the method, and havenow successfully completed more than 100 customer projects.

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