Is it time to reconsider your HCP Coverage analysis?
Your HCP analysis should be both reactive to broader populations of HCPs and more specific to HPCs likely to be in the final product. However, with current methods, based on 2 D Page and Western Blot, it is difficult to know if both of these conditions are met. If you’re in Boston today, you can… Read whole story
Review of BEBPA HCP Conference 2019 – Key topics & take-home messages
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
Alphalyse scientist successfully defends PhD thesis
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
Video: What is the most Critical Quality Attribute of Biologics?
Many biopharmaceutical proteins are cross-linked by disulfide bridges. They help increase the durability and protect from proteolytic degradation. The disulfide bridge pattern can therefore influence the efficacy and integrity of the final drug product. Thus disulfide bridge mapping is one of the services we often recommend for characterization of biologics. In this short video you follow… Read whole story
HILIC – Unravel the Glycan Structure of your Antibody
We just published a new blog post on the use of HILIC analysis of glycosylations. In order to get a complete picture of your antibody’s glycosylations you need an analysis at different levels. Typically, you conduct the following analyses: Top-down analysis of the intact mAb. Middle-up approach of the mAb subunits (LC, Fd´, and scFc)…. Read whole story
Sciex and Alphalyse team up at WORLD ADC in London
In cooperation with SCIEX, Thomas Kofoed gives a short speak on ADC analysis at the coming World ADC meeting in London. Meet him at Sciex stand no9 for more information on the the subject of Antibody drug conjugates (ADCs). The World ADC meetings provide superb networking for the scientific community working on ADCs within Biotech, Pharma… Read whole story
Easy method for following specific HCPs through purification steps
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
Don’t rely solely on ELISA for HCP evaluation in process development
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
Document process-related residual protein in final drug substance
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
2019 New Year Resolution: No more Western Blotting!
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
Poster: Detailed analysis of Host Cell Protein in process samples
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
Video: Magdalena explains her MAM project sponsored by A4B
Magdalena joined Alphalyse back in April, when she came from a position at Genovis AB in Sweden. She takes part in the joint European PhD-fellowship program – also known as Analytics for Biologics (A4B). For her PhD project Magdalena now focuses on developing Multi Attribute Monitoring (MAM) LC-MS methods. Eventually, we will use these new methods… Read whole story
Sheila Maibom-Thomsen successfully defends PhD thesis
Friday we celebrated Sheila Maibom-Thomsen, who has conducted a PhD-study at the University of Southern Denmark. Sheila did her PhD research in cooperation with Alphalyse, developing novel approaches for characterization of biopharmaceutical monoclonal antibodies. Part of the project was done in collaboration with the Swedish company Genovis. As a result new enzymes for mAb analysis… Read whole story
HCP presentation at “Biologics Characterization Made Easy” in CPH
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
Alphalyse participates in the “Staff Relay Race by DHL”
Our skillful protein scientist, Anette Rasmussen, often goes the extra mile to help out our customers with their protein samples and questions related to protein analysis. Yesterday she showed great spirit when she ran a little over 9 miles (15 km) in the Staff Relay Race by DHL in Odense, to help out two of… Read whole story
Training on the Sciex X500B QTOF
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.
Developing new analysis in collaboration with customers and suppliers
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
BEBPA 2018 – Key topics and take-home messages
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
Ejvind Mortz presents at ESAC by AMCHAM
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
Magdalena Sandberg joins our team in European PhD-fellowship program
Magdalena Widgren Sandberg just joined our team. She will participate in the joint European PhD-fellowship program known as A4B – Analytics for Biologics. The A4B project members work on improving therapeutic proteins. For example to improve on the production, purification, and analysis of therapeutic proteins. For her PhD project Magdalena will focus on Multi Attribute Monitoring… Read whole story