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Why we need orthogonal HCP analysis for mAbs

Is the “needle in the haystack” ruining your mAb product?
Determining the HCP amount to a sparse sum using ELISA does not rule out that the product may contain ‘problematic’ HCPs – that may degrade the product or alter the function. Watch this webinar to learn why you need an orthogonal method to ELISA to investigate your mAb for potentially problematic HCPs – down to and below 1ppm.

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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.

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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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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.

mass spectrometry cro protein analysis lab testimonials

"We are very pleased with the work of Alphalyse, who provide us with high-quality tests of our recombinant products. Perhaps most importantly, we can ship them hundreds of samples at once and always receive the analytic results shortly after"
GTP Technology, FranceGrégori Gross - PhD, Bid Manager

"We really enjoy collaborating with Alphalyse as part of our optimization of manufacturing processes. Not only do we gain access to their hands, but we also get to pick their brains for mass spectrometry knowledge"
Y-mAbs Therapeutics Inc, USATorben Lund-Hansen - PhD, SVP, Head of Technical Operations

"Alphalyse´s HCP analysis saved us for development of an ELISA assay that may not have worked anyway. The HCP team provided very competent explanations of test results and was very open in discussing the method capabilities"
Statens Serum Institut, DenmarkMax Kristiansen - MSc, Special Consultant Assay Development

"Using the Alphalyse LC-MS/MS coverage method in HCP-ELISA selection, we estimate a savings of approximately $1M and, likely, one year of development time"
SAVARA Aps, DenmarkLars Skriver - Senior Science Officer

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.

15+ years of expertise 1000+ analysis projects
CRO expertise obtained through more than 100 projects yearly, using top-of-the-line mass spectrometry equipment
500 biopharmaceutical customers worldwide
Our lab and offices in Denmark and the US provide worldwide analysis services
150+ HCP projects using mass spectrometry
When it comes to HCP analysis by MS we are probably the most experienced lab in the world

As a CRO, we have obtained a lot of knowledge 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 for the characterization of proteins was published in 2008. Since then we have developed a unique method of analyzing HCPs using mass spectrometry, and we have now successfully completed more than 150 HCP customer projects.

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