Moving LC-MS HCP Analysis into a GMP Environment
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
Alphalyse reaches order number 20.000
Yesterday we reached another milestone, when we sent out our order confirmation numbered 20.000! Thank you to our many loyal customers since 2002, we look forward to serving you also in the future
New HPLC just arrived
We are excited to unpack another HPLC for our growing instrument park. In the last year we saw a large expansion in analysis of intact proteins. This instrument will thus be dedicated to our HILIC and SEC analysis.
Webinar 10 March: Tool for data-driven process development
How consistent is the process and impurity profile of your biologics? As part of the process performance qualification (PPQ), we see that companies who develop new biologics, benefit greatly from applying mass spectrometry for comparing impurities between PPQ batches: In detail, they can document the performance of the process – and accumulate great documentation for… Read whole story
Alphalyse hires new quality assurance manager
We have added even more power to our team with our new skilled colleague Esben Fisker! Esben joins us as quality assurance manager. He brings experience from Schroll Medical ApS and Novo Nordisk in analytical quality control, laboratory procedures, validation, qualification, and statistical process control, which he will use for improving the quality assurance system… Read whole story
Meet our two new protein scientists
Sigurd Frederiksen is our new instrument specialist. Sigurd has a robust background in mass spectrometry and proteomics methods from University of Southern Denmark. He has acquired extensive knowledge on characterizing single proteins, focusing on MS/MS fragmentation analysis of peptides and post translational modifications using Thermo Fisher Scientific Orbitrap Fusion Lumos and Q Exactive mass spectrometers…. Read whole story
Study: Comparison of impurity profiles & problematic HCPs – in mAbs
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
Review of BEBPA’s HCP Conference 2020
Key topics & take-home messages
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 event. The BEBPA organizing committee had assembled a great program with high level scientific talks, audience… Read whole story
Successful Enterprise of 2020 Award
What to say, when you receive a prize formed as a DNA helix when you are actually an expert on proteins…? ? Thanks, of course!We are very proud that the award shelf now also holds a “Successful Enterprise 2020” prize from BDO Danmark and Spar Nord – with Alphalyse being one of only 5 companies in the region to… Read whole story
Live webinar on 29 & 30 September: Impurities in cell & gene therapies
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
Alphalyse A/S is hiring: Two protein scientists needed
We are looking for two more analytical protein scientists to join our laboratory in Odense, Denmark. Would you like to join a team who performs high quality protein analysis for our biopharma customers – which they use in their development of novel protein drugs? As analytical protein scientist at Alphalyse A/S your job tasks will… Read whole story
Flemming Holm Bergholdt joins Alphalyse
Welcome to our new team member Flemming Holm Bergholdt. With his background in Genetics and Immunology, Flemming is a great addition to our Impurity Analysis Team. You will most likely meet him on projects involving Host Cell Protein, and Coverage Analysis – where he will be applying his skills within ELISA and LC-MS sample preparation…. Read whole story
Research article published: Novel coverage analysis by ELISA-MS™
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
Article: How to measure HCP levels in new expression systems
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
Webinar: HCP analysis for data-driven process development
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
Alphalyse A/S moves into new headquarters
It was quite nerve-wracking to watch the SCIEX TripleTOFs get moved into the new labs. Since the regular staircase was too steep and long, we had to get them in through the fire-escape on the 1st floor! You can watch a video of it here >> We are now getting adjusted to the new surroundings… Read whole story
Inga Boll receives PhD degree from SDU
Our newly hired Inga Boll successfully defended her PhD on Friday 6 March. Inga thus became one of the last students who was allowed to defend their PhD at Syddansk Universitet – University of Southern Denmark – before it temporarily closed all activities in response to the COVID-19 pandemic that has now hit most of… Read whole story
Webinar: Design the optimal HCP Analysis strategy
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
3 new team members join Alphalyse
Two new members joined our team this week: Stine Thyssen (left) and Inga Boll (middle). We asked them what they anticipate the most, working at Alphalyse: “I look forward to using my expertise in protein chemistry to help our customers with their protein analysis. I am happy to be a part of Alphalyse where we… Read whole story
Alphalyse A/S moving into new premises next spring
Soon, we’ll be moving our Headquarters to a new central location in Odense, Denmark with more than twice the amount of space – so we can expand our team and add even more instruments The builders just started the transformation, to make the building fit our needs – with state-of-the-art laboratories and open office space…. Read whole story