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
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
Now there is a plan 🅱️: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 /… Read whole story
Current guidelines recommend using several orthogonal methods to determine your ELISA’s coverage of host cell protein (HCP). Now Alphalyse and Biogenes pool our know-how and 20 years of experience in the HCP field for the combined use of our respective methods. We thus offer several HCP coverage methods: LC-MS-based coverage analysis (ELISA-MS™), Immunoaffinity Chromatography IAC… 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
[Cell/Gene therapy] Are you prepared for FDA’s impurity concerns? The guidelines state that you should characterize impurities and monitor process performance parameters for process consistency. But what if no good impurity ELISA is available? Join Ejvind Mørtz for an exploration of the 𝐥𝐢𝐦𝐢𝐭𝐚𝐭𝐢𝐨𝐧𝐬 𝐨𝐟 𝐭𝐫𝐚𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐦𝐞𝐭𝐡𝐨𝐝𝐬 (𝐞𝐠. 𝐄𝐋𝐈𝐒𝐀, 𝐒𝐃𝐒 𝐏𝐀𝐆𝐄, 𝐖𝐞𝐬𝐭𝐞𝐫𝐧 𝐛𝐥𝐨𝐭𝐭𝐢𝐧𝐠) for monitoring of… 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
Get free access to our latest publication on HCP analysis by LC-MS and ELISA with data from PPQ runs and regulatory license applications. https://www.alphalyse.com/customer-support/publications-references/article-monitoring-impurities/ Lead authors: Katrine Pilely and Martin Rask Johansen.
It can be challenging to find a suitable commercial ELISA to monitor the process-related impurities in cell and gene therapies. E.g., due to the use of a novel cell line because there are impurities from multiple organisms. On October 5, Ejvind Mortz shows how Mass spectrometry (LC-MS) provides unrivaled HCP quantification and high reproducibility of… Read whole story
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
💠 Why:Monoclonal antibody products (mAbs) are often relatively pure due to the efficient removal of host cell proteins (HCPs) using protein A purification and the following polishing steps. However, determining the HCP amount to a sparse sum does not rule out that the product may contain ‘problematic’ HCPs at low – but still critical –… 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
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
Review of BEBPA HCP conference 2022 >>Review of BEBPA HCP conference 2021 >>Review of BEBPA HCP conference 2019 >> 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
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
If you work with the process development of biologics, you probably rely on HCP ELISAs for Host Cell Protein analysis. But why not apply an orthogonal method as well? By integrating mass spectrometry-based analysis in your workflow, you get a tool for intelligent process optimization you can skip comprehensive purification matrices you can choose the… Read whole story
Your HCP analysis should be both reactive to broader populations of HCPs and more specific to HCPs likely to be in the final product. However, with current methods, based on 2D PAGE and Western Blot, it is difficult to know if both of these conditions are met. If you’re in Boston today, you can experience… Read whole story