Have you ever wondered.. If mAb products on the market contain small amounts of problematic Host Cell Protein (HCP) – undetected by old analysis techniques available at the time of drug development? How similar the individual HCPs of biosimilars and the originator really are? We did, and therefore set up an investigational study. Comparison of… Read whole story
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, still 130 participants, consisting of HCP experts from biopharma, service- and technology providers and regulatory agencies, attended the event. The BEBPA organizing committee had assembled a great program with high level scientific talks,… Read whole story
Are you submitting an IND for a Human Gene Therapy?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? In just 30 minutes we show you how to select the best ELISA for your project use mass spectrometry to quantify… 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 production of recombinant biopharmaceuticals to… 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 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
Did you know that a ‘good’ HCP analysis strategy should … … be able to detect and document both broad-level HCPs and specific (critical) HCPs? In this 30 minute webinar Ejvind Mortz, COO, covers how to design a strategy for: • Detecting and documenting HCP impurities in process samples and final drug • Making a… Read whole story
Reproducible sample preparation is perhaps the most important part of protein analysis. See how we managed to fully automate complex sample preparation for high reproducibility – and create a good work environment for our team using an Eppendorf Automation robot. Read article on Eppendorf website >>
Alphalyse now launches a new reproducible method for detecting which individual impurities are measured Join our webinar on Wednesday, 18 September 2019 to learn more: Attend if you are a manager or scientist in R&D or process development and concerned about the Host Cell Proteins (HCPs) in your biologic. After participating, you.. → Possess… 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
BEBPA’s 7th annual Host Cell Protein Conference May 15-17th took place in Los Angeles, California. It once again attracted HCP experts from biopharma, service- and technology providers, and regulatory agencies. The organizing committee had again put together a great mix of talks, workshops and round-table discussions. Very importantly, there was also plenty of time for… Read whole story
CONGRATULATIONS to Katrine Pilely who Tuesday successfully defended her PhD thesis at the University of Copenhagen. Under supervision of Professor Peter Garred, Katrine Pilely studied how cholesterol crystals activate the immune system. This happens through complement-mediated mechanisms, and therefore contribute to the pathophysiology of atherosclerosis. Katrine further showed how to inhibit the upstream cholesterol crystal-induced… Read whole story
See how Rikke Lund’s team helps with removal of host cell protein contaminants from recombinant protein with the use of mass spectrometry. In this short video Rikke gives examples of customer results. The host cell protein analysis provides the customer with both identity and quantity of individual HCPs. This makes it possible to compare and identify differences… Read whole story
Why it’s a bad idea to rely solely on ELISA assays for HCP evaluation in process steps. – And 3 remarkable improvements you gain from adding a LC-MS based HCP assay. On Thursday 28 February Thomas Kofoed conducts a short webinar. Learn how an LC-MS based HCP-assay greatly decreases the risk of failing due to Host… Read whole story
Standard analyses do not detect trace amounts of protein process additives, otherwise known as residual proteins. Examples include growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, etc. Instead you can now use a customized LC-MS assay, developed by Alphalyse. It will detect residual proteins of interest – in both your final drug substance… Read whole story
Yes, we are determined to wipe out Western Blotting as the standard HCP-ELISA coverage analysis. To meet customer demand, our HCP team is thus stepping up with yet another team-member; Katrine Pilely. Since new year, Katrine has taken part in the Alphalyse onboarding program and she is now ready to provide customers with useful information… Read whole story
Together with Sciex AB we have made a scientific poster on detailed analysis of the Host Cell Protein in process samples. The poster describes our fast LC-MS method that is based on SWATH technology. Since the method is generic, you can apply it to biopharmaceutical processes within a few weeks. The method can be used… Read whole story
On 2 October, Thomas Kofoed presented on “Identification and Absolute Quantification of Host Cell Proteins using SWATH Mass Spectrometry.” SCIEX and Phenomenex hosted this event on the recent developments in analytical technologies for biopharmaceutical characterization using Mass Spectrometry and Capillary Electrophoresis. Experts in the field presented the latest innovations in: Routine and advanced workflows for… Read whole story
Kerstin Poll from Sciex is teaching us how to get the most out of our new X500B QTOF. Soon we will be able to help you with new quantitative peptide maps by MAM. We will also be able to find variants of protein pharmaceuticals, and make even better analysis of product related impurities.
Not satisfied with your current protein analysis method? Let’s improve it! In this new article you get an example of how we invent new analysis and improve on existing methods in collaboration with our customers and suppliers – leading to cutting-edge LC-MS technology that specifically addresses your challenges. Labiotech.eu ►https://www.labiotech.eu/revealing-identity-hcp-sciex “It’s a perfect example of… Read whole story