Today’s labs are challenged to answer more questions from increasingly diverse and complex samples – but how? For the past couple of weeks, our experts in Analytical Characterization have been busy setting up a new Waters Corporation Acquity HPLC, which will provide even faster mass detection to supplement our LC-MS analysis. By staying on… Read whole story
One challenge when developing next-gen biotherapeutics is identifying and eliminating undesired post-translational modifications (PTMs). PTMs can occur if biotherapeutic proteins are inadvertently exposed to stressors such as suboptimal pH values or temperature changes. Traditional methods for peptide mapping used in the development, characterization, and quality control of biotherapeutics hold several limitations. Particularly regarding detailed analysis… Read whole story
Alphalyse and Bavarian Nordic A/S significantly shorten the time necessary to document HCP impurities in COVID-19 vaccine candidate for Phase 3 clinical trial – through the world’s first MS-based HCP analysis under GMP conditions ODENSE, Denmark, November 3, 2022 –Alphalyse has performed the world’s first GMP-certified mass spectrometry (MS)-based Host Cell Protein (HCP) analysis for… Read whole story
We at Alphalyse are honored to have received the “Succesvirksomhed 2022” award from Uffe Staal Knudsen (far left) and Thomas Brorsen Jensen (far right) on behalf of Spar Nord Bank and BDO Accounting. This business award recognizes Denmark’s top 1,000 successful enterprises that show continuous organizational growth and strong financial results. Thus, they contribute to… Read whole story
We are excited to welcome two new Alphalyse colleagues, who will join us in providing excellent service, a high level of expertise, and a fast turnaround for our growing number of customers. Please meet Tine Nielsen (Left) and Line Greve (Right). Tine holds an MSc in Biomedicine and has worked as a quality control chemist,… Read whole story
To further strengthen our high level of service, expertise, and quality of analysis we now introduce three new Alphalyse colleagues: Vicki Nautrup Nielsen (right), Dean Pedersen (middle), and Cecilie Hovitz Lautrup-Larsen (left). 👩🔬Vicki is a familiar face, having worked at Alphalyse in 2020 as a biomedical laboratory scientist. She brings 15 years of laboratory experience… Read whole story
Is your viral vaccine pure and consistent? One of the biggest challenges in developing viral vaccines is ensuring and documenting that the downstream process consistently produces a safe product – with low Host Cell Proteins (HCPs) levels. Join Ejvind Mortz on June 29: Learn how one LC-MS assay identifies and quantifies all proteins in the… Read whole story
Meet Victor Chrone (left) and Vasileios Tsiamis (right) from our newly formed bioinformatics department. They are experts in computational biomedicine, including machine learning and big data management. We will benefit from their expertise e.g., in developing tools to quickly analyze datasets generated by mass spectrometry and combining learnings from more than 250 host cell protein… Read whole story
Review of BEBPA HCP conference 2021 >>Review of BEBPA HCP conference 2020 >> June 2022 By Thomas Kofoed, Rikke Lund and Ejvind Mørtz, Alphalyse On May 16-19, we attended BEBPA’s annual HCP conference. The organizing committee had prepared an exciting conference program. It consisted of high-level scientific talks, audience poll questions, and panel discussions on… Read whole story
If you cannot get an ELISA to work, you can rely on MS analysis under GMP conditions. Last 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 / Host Cell Proteins, using our… Read whole story
Who is our intern Martine Mørck Taagholt?She is working on a project to optimize parts of the Alphalyse ELISA-MS™ 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-MS™ 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. 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 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 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, 🔹 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
Review of BEBPA HCP conference 2022 >>Review of BEBPA HCP conference 2020 >>Review of BEBPA HCP conference 2019 >> 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