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 remove host cell protein contaminants from recombinant protein. In this short video Rikke gives examples of customer results. The HCP analysis provides the customer with both identity and quantity of individual HCPs. This makes it possible to compare and identify differences of various production batches. In addition, the method is a… 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. It will detect protein residuals of interest – in both your final drug substance and process samples…. 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://labiotech.eu/revealing-identity-hcp-sciex “It’s a perfect example… 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
Today you can meet Ejvind Mortz at the ESAC meeting in Copenhagen. Come and learn how Host Cell Protein analysis by SWATH LC-MS provides: Identification & quantification of each HCP. – Which makes it very easy to compare individual HCPs for both different process samples & final batches. Direct application of the analysis to your samples…. Read whole story
So why not spent 30 minutes to read this new article on HCP analysis by SWATH® LC-MS? “Evaluation of spectral libraries and sample preparation for DIA-LC-MS analysis of host cell proteins. A case study of a bacterially expressed recombinant biopharmaceutical protein”. Use this link to get 50 days’ free access to the full article. No… Read whole story
Over the past few weeks, Hannah and Michael (Eppendorf) have helped us set up our first automated protein sample preparation protocol for biopharmaceuticals on “Pippi” (epMotion pipetting system). Pippi is our new Cobot (Collaborative Robot) which will help us optimize the work in our digest lab. The goal is to automate standard procedures to further… 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
“Generic ELISAs may underestimate Host Cell Protein content in your drug-product. Mass spectrometry is more accurate and sensitive than both generic and process-specific ELISAs, and much faster to set up than process-specific ELISAs. However, what really makes Mass spectrometry stand out is its ability to identify and quantify each specific Host Cell Protein.” These were… Read whole story
The BEBPA Host Cell Protein (HCP) Conference 2017 was again held in charming San Francisco with HCP experts from all over the world. 140 engaged participants from biopharma companies, instrument vendors, CRO’s and regulatory authorities had a very good HCP conference with high level presentations and an excellent forum for discussion of ELISA and orthogonal method. Kevin Van… Read whole story