In these live broadcasts, leading cell and gene therapy, phage, and vaccine developers present approaches to the CMC challenges.
Learn more and see the full program
Are you struggling to document that your downstream process consistently produces a safe product? In this webinar, you will learn how to quickly measure and compare residual protein in any type of vaccine.
Explore how to improve vaccine purity using LC-MS
Now you can rethink your HCP assay strategy with mass spectrometry (MS)-based HCP analysis available from a GMP-certified lab. It is ideal when there is no sufficient generic ELISA for your cell line – or when the time to develop a process-specific ELISA is limited, e.g., for phase 2 and 3 clinical trials.
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In CMC development, one of the biggest challenges is ensuring and documenting that the downstream process consistently produces a safe product. However, the complex bioproduction of of cell therapies, gene teherapies and viral vaccines produce a diverse range of proteins, which we must monitor for consistency.
Learn more about the challenges and solutions
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
Explore our HCP analysis services
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
For the past 20 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 Bioways, 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
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 you bring your processes forward, by analyzing biopharmaceutical proteins using top-of-the-line equipment.
CRO expertise obtained through more than 100 projects yearly, using top-of-the-line mass spectrometry equipment
Our lab and offices in Denmark and the US provide worldwide analysis services
When it comes to HCP analysis by MS we are the most experienced lab in the world, having run 350+ projects so far
As a CRO, we have obtained a lot of knowledge through our many customer projects
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.
A great place to start is a webinar. You can find on-demand webinars at https://www.alphalyse.com/webinars/
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.
Which analyses should be included in biopharmaceutical protein analysis?
Where can I get more information about Host Cell Protein analysis by mass spectrometry?
What makes Alphalyse experts in HCP analysis?