Latest news about Corporate

13 May 2021

FDA approves IND with LC-MS HCP analysis

Last week we got exciting news: FDA approved an Investigational New Drug Application (IND) for one of our clients who used ONLY our mass spectrometry data – NO ELISA data – to analyze the host cell proteins (HCPs) in their biological drug. The approval marks a significant advancement for HCP analysis by mass spectrometry, where… Read whole story

13 April 2021

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

26 March 2021

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

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.

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

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, 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

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

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

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

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

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

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

3 October 2019

Christina Johannsen on secondment at Alphalyse for 2 months

Join us in welcoming Christina Johannsen. She will be on secondment at Alphalyse for the next 2 months, and study quantitative methods for biologics. Christina joins Magdalena Sandberg in performing PhD research. Especially intact mass analysis and peptide mapping on a SCIEX X500b mass spectrometer. Thus, we plan to use their new methods for better… Read whole story