Now there is a plan π ±οΈ:If you cannot get an ELISA to work, you can rely on MS analysis under GMP conditions. πLast week, Alphalyse received our GMP certificate, officially stating that we are approved for performing quality control of biological API. So now we can set up validated mass spectrometry assays for analyzing residual impurities /… Read whole story
Who is our intern Martine MΓΈrck Taagholt?She is working on a project to optimize parts of the Alphalyse ELISA-MSβ’ method. Martine is a Biomedicine MSc student at the University of Southern Denmark – SDU. Here’s what Martine thinks about doing a study-related project for a biotech company like Alphalyse: A company project is a fantastic… Read whole story
Our team has worked for more than eight years to develop a robust method and solve the challenges related to the MS analysis of HCPs. By now, we have used the assay in more than 200 customer projects, and we have worked passionately to make the test results easy to understand and use. We are… Read whole story
Today, we submit our application for manufacturing authorization to the health authorities, soon enabling us to perform quality control of active pharmaceutical ingredients according to EU and US GMP. The submission concludes a three-year investigation of our mass spectrometry-based Host Cell Protein analysis (HCP-MS) method’s robustness and reproducibility across more than 200 projects. Common for all projects is… Read whole story
In just 30 minutes, you can learn how to use ELISA-MSβ’ coverage analysis to: a) Make ELISA kit bridging studies – when your supplier switches to a new batch of capture and detection antibodies b) Check if the coverage of your ELISA is good enough – especially for uncommon expression systems c) Select the ELISA… Read whole story
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. Sindhuβs… Read whole story
Way to go, Alphalyse team! ππ 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 Nπ¨π―ππ₯β+βππ ππ π¦π¨ππ’ππ’ππππ’π¨π§ π’π§ π«π‘ππ-πππ ππ±π©π«ππ¬π¬ππ π’π§ π. ππ¨π₯π’: Authors: Magdalena Widgren Sandberg, Jakob Bunkenborg, Stine Thyssen, Martin Villadsen and Thomas Kofoed The scientists found and identified a novel post-translational modification in fermentation batches of… Read whole story
It allows us to set up methods to identify and quantify individual proteins as low as 0.1 ppm. Furthermore, πΉ It has a unique ability to quantify specific proteins, e.g. HCPsπΉ It can be fully GMP validatedπΉ 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 JΓ€pelt 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: πHis expertise includes peptide quantification using the isobaric mass tag, phosphorylation enrichment, and several chromatography methods. πHumberto holds a PhD in Biochemistry from the Leibniz Institute for Analytical Sciences (ISAS) in Dortmund, Germany. πHe 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 BEBPAβs 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 for use in e.g. glycosylation analysis. 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 BEBPAβs 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
This is Victor Chrone – our new laboratory student assistant. Victor is very competent in organizing and helping out in the laboratory – and we are already very dependent on his skills in making buffers and other stock products. Victor is a Master’s student at SDU where he majors in computational biomedicine. A very exiting… Read whole story