News

Agilent 1260 HPLC for HILIC analysis
3 March 2021

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.

HCP assay by Mass Spectrometry - A tool for process development
18 February 2021

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

29 January 2021

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

10 December 2020

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 posttranslational modifications using Thermo Fisher Scientific Orbitrap Fusion Lumos and Q Exactive mass spectrometers. At… Read whole story

New webinar on impurities in mAbs
13 November 2020

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

HCP Conference 2020 - BEBPA
31 October 2020

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, still 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,… Read whole story

Successful enterprise of the year 2020
24 September 2020

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

Webinar - Impurities in cell & gene therapies
15 September 2020

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

7 September 2020

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 Bergholt, Alphalyse
3 August 2020

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

23 July 2020

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

Future-proof the analysis of host cell proteins in biopharma
22 June 2020

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

31 May 2020

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 CRO Denmark
1 April 2020

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

12 March 2020

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

20 February 2020

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

New employees Alphalyse
6 February 2020

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

5 December 2019

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

13 November 2019

We’re hiring: 3 new positions in our Danish headquarters

We seek two additional analytical protein scientists and a laboratory technician for our headquarters in Odense, Denmark to help develop analytical methods for protein characterization, and to perform analysis for our biopharma customers. Our most important asset is our team of highly skilled scientists, who are experts in characterization of biopharmaceutical proteins. Join our dedicated team… Read whole story

fast turnaround at Alphalyse
14 October 2019

Alphalyse awarded “Best Digital Transformation” in Southern Denmark

Whoop whoop!We won the BDO award for best digital transformation in the region of Southern Denmark! The award was accepted at a ceremony last week by a proud Thomas Kofoed (CEO at Alphayse) who said: “It was clear to us from day one that we had to digitalise our processes and we started with our… Read whole story


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