Video: 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
Webinar: Don’t rely solely on ELISA assays 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
Need documentation of process-related residual protein in final drug substance?
Standard analyses don’t detect trace amounts of protein process additives (residual proteins). For instance growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, etc. Instead you can now use a customized LC-MS assay to detect protein residuals of interest – in both your final drug substance and process samples. Advantages include low-to-sub ppm detection… 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
Scientific 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 Copenhagen
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 Widgren Sandberg just joined our team as part of a joint 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
Got plans for Easter?
So why not 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 sign up required (expires… Read whole story
Better quality, reproducibility and capacity for high through-put biopharmaceutical analysis
At Alphalyse we are committed to keep up with the evolving needs of our customers. Right now, we are implementing several changes in our laboratory, to further improve our capacity and quality, optimize our workflows, and benefit you through better reproducibility and turnaround time. Strengthening our team On 1st March, Martin Villadsen joined our team… Read whole story
Setting up Cobot for automated protein sample preparation for biopharmaceuticals
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
Are you worried about small peaks or shoulders in your HPLC chromatogram?
Sometimes your UV-HPLC chromatogram shows small peaks or shoulders. Now we can identify and characterize the peaks observed by your UV. So you can easily confirm if it has detected a product-related impurity. Simply transfer your HPLC analysis to our laboratory. Then we will couple it to a mass spectrometer and make a full characterization… Read whole story
New project collaboration with Affibody AB on detailed HCP analysis
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
Middle Level LC-MS Characterization of Site-Specific and Random ADC
Last month, the latest findings on antibody drug conjugates (ADCs) were presented at the European Antibody Congress in Basel, Switzerland. Genovis AB exhibited our joint poster titled “Middle Level LC-MS Characterization of Site-Specific and Random ADC – Impact of Conjugation Method on In Vivo Tumor Uptake”. In this work Alphalyse and Genovis AB collaborated on characterizing… Read whole story