Your ProfessionalContract Analysis Partner in biologics development

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Phone: +45 6310 6500 US: (650) 543-3193
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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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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.

"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 MS equipment
500 biopharmaceutical customers worldwide
Our offices in Denmark and the US provides worldwide analysis services
100+ 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 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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