The close proximity of Syddansk Universitet – University of Southern Denmark (SDU) to the Alphalyse Headquarters gives us unique access to very well-educated and specialized employees. This month, we are thus excited to welcome two SDU alumnae, Freja and Sindhu, to our team Sai Sindhu Thangaraj just finished her PhD Thesis in Cardiovascular Inflammation. Sindhu’s… Read whole story
Way to go, Alphalyse team! 🚀👏 We are the proud recipients of the BDO award for successful enterprises – for the 3rd year in a row! The award goes to companies that show continuous growth for five consecutive years while improving their solvency. We dedicate the award to our loyal employees – Alphalyse would be… Read whole story
New article by scientists at Alphalyse on using mass spectrometry to measure a product-related impurity in a novel biologic: https://link.springer.com/article/10.1007/s00726-021-03004-9 𝐂𝐡𝐚𝐫𝐚𝐜𝐭𝐞𝐫𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐚 𝐧𝐨𝐯𝐞𝐥 + 𝟕𝟎 𝐃𝐚 𝐦𝐨𝐝𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐫𝐡𝐆𝐌-𝐂𝐒𝐅 𝐞𝐱𝐩𝐫𝐞𝐬𝐬𝐞𝐝 𝐢𝐧 𝐄. 𝐜𝐨𝐥𝐢: Authors: Magdalena Widgren Sandberg, Jakob Bunkenborg, Stine Thyssen, Martin Villadsen and Thomas Kofoed The scientists found and identified a novel post-translational modification in… Read whole story
It allows us to set up methods to identify and quantify individual proteins as low as 0.1 ppm. Furthermore, 🔹 It has a unique ability to quantify specific proteins, e.g. HCPs🔹 It can be fully GMP validated🔹 And it is an excellent addition to our existing machinery
To keep up with the growth in impurity analysis, we have hired two new experienced PhD-level scientists for our team; Rie Bak Jäpelt and Anette Holck Draborg. Rie brings immense experience in mass spectrometry method development and validation, especially for quantitative analysis.She also holds strong qualifications within quality control of analytical methods.For more than 10 years, Rie has… Read whole story
Welcome to Humberto Jorge, the new protein analyst at Alphalyse. Here are a few things you should know about Humberto: 👉His expertise includes peptide quantification using the isobaric mass tag, phosphorylation enrichment, and several chromatography methods. 👉Humberto holds a PhD in Biochemistry from the Leibniz Institute for Analytical Sciences (ISAS) in Dortmund, Germany. 👉He comes… Read whole story
Review of BEBPA HCP conference 2020 >>Review of BEBPA HCP conference 2019 >>Review of BEBPA HCP conference 2018 >> May 2021, by Rikke Raaen Lund and Thomas Kofoed, Alphalyse BEBPA’s 9th annual Host Cell Protein Conference took place, again as a virtual conference, on May 17-19, 2021. The BEBPA organizing committee once again assembled an exciting… Read whole story
Last week we got exciting news: FDA approved an Investigational New Drug Application (IND) for one of our clients who used ONLY our mass spectrometry data – NO ELISA data – to analyze the host cell proteins (HCPs) in their biological drug. The approval marks a significant advancement for HCP analysis by mass spectrometry, where… Read whole story
For new biologics under development, validated HCP impurity assays are needed for the GMP release test to show product purity. However, it has been challenging to move HCP analysis by LC-MS into QC laboratories due to the complexity of the sample preparation and data analysis, the sophistication of the high-end mass spectrometers, and the lack… Read whole story
Yesterday we reached another milestone, when we sent out our order confirmation numbered 20.000! Thank you to our many loyal customers since 2002, we look forward to serving you also in the future
We are excited to unpack another HPLC for our growing instrument park. In the last year we saw a large expansion in analysis of intact proteins. This instrument will thus be dedicated to our HILIC and SEC analysis.
We have added even more power to our team with our new skilled colleague Esben Fisker! Esben joins us as quality assurance manager. He brings experience from Schroll Medical ApS and Novo Nordisk in analytical quality control, laboratory procedures, validation, qualification, and statistical process control, which he will use for improving the quality assurance system… Read whole story
Sigurd Frederiksen is our new instrument specialist. Sigurd has a robust background in mass spectrometry and proteomics methods from University of Southern Denmark. He has acquired extensive knowledge on characterizing single proteins, focusing on MS/MS fragmentation analysis of peptides and post translational modifications using Thermo Fisher Scientific Orbitrap Fusion Lumos and Q Exactive mass spectrometers…. Read whole story
Review of BEBPA HCP conference 2021 >>Review of BEBPA HCP conference 2019 >>Review of BEBPA HCP conference 2018 >> Due to Covid-19 related travel restrictions BEBPA’s 8th annual Host Cell Protein Conference October 26-28 was conducted as a virtual symposium. Fortunately, 130 participants, consisting of HCP experts from biopharma, service- and technology providers, and regulatory agencies, attended the… Read whole story
What to say, when you receive a prize formed as a DNA helix when you are actually an expert on proteins…? ? Thanks, of course!We are very proud that the award shelf now also holds a “Successful Enterprise 2020” prize from BDO Danmark and Spar Nord – with Alphalyse being one of only 5 companies in the region to… Read whole story
We are looking for two more analytical protein scientists to join our laboratory in Odense, Denmark. Would you like to join a team who performs high quality protein analysis for our biopharma customers – which they use in their development of novel protein drugs? As analytical protein scientist at Alphalyse A/S your job tasks will… Read whole story
Welcome to our new team member Flemming Holm Bergholdt. With his background in Genetics and Immunology, Flemming is a great addition to our Impurity Analysis Team. You will most likely meet him on projects involving Host Cell Protein, and Coverage Analysis – where he will be applying his skills within ELISA and LC-MS sample preparation…. Read whole story
In this research article published in the July/August issue of Biotechnology Progress, our scientists present a novel coverage method combining ELISA-based immunocapture with protein identification by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Click to download article >> Monitoring host cell proteins (HCPs) is one of the most important analytical requirements in the production of recombinant biopharmaceuticals… Read whole story
The increasing prevalence of new expression systems in biomanufacturing, new modalities in biotherapeutics, and new analytical technologies such as LC-MS/MS, is likely to lead regulators towards the requirement for more HCP data from biopharma manufacturers. This article addresses the issues and proposes a new way of securing a comprehensive, 4-dimensional digital record of HCP data… Read whole story
It was quite nerve-wracking to watch the SCIEX TripleTOFs get moved into the new labs. Since the regular staircase was too steep and long, we had to get them in through the fire-escape on the 1st floor! You can watch a video of it here >> We are now getting adjusted to the new surroundings… Read whole story