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 quantification and high reproducibility of each… 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 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
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
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
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
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
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
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
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
The BEBPA HCP meeting 2018 was this time held in Europe – more precisely in beautiful Dubrovnik, Croatia. The conference was again very well planned with a great mix of talks from industry, academia and regulatory authorizations. The BEBPA HCP meeting is the perfect place to get the full picture about current best practice for HCP… Read whole story
Just before Christmas, COO Ejvind Mortz visited beautiful Stockholm in Sweden. The purpose of the trip was to discuss the final details of our new collaboration with Affibody AB on analysis of Host Cell Protein (HCP) in biopharmaceuticals over the next 12 months. Alphalyse recently finished a 3-year development project with University of Southern Denmark and… Read whole story