Webinar: 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, 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
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
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
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
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
‘Pippi’ automates complex & variable protocols for protein analyses
Reproducible sample preparation is perhaps the most important part of protein analysis. See how we managed to fully automate complex sample preparation for high reproducibility – and create a good work environment for our team using an Eppendorf Automation robot. Read article on Eppendorf website >>
Webinar: Which HCP impurities is your ELISA assay missing?
Alphalyse now launches a new reproducible method for detecting which individual impurities are measured Join our webinar on Wednesday, 18 September 2019 to learn more: Attend if you are a manager or scientist in R&D or process development and concerned about the Host Cell Proteins (HCPs) in your biologic. After participating, you.. → Possess… Read whole story
Alphalyse receives BDO award for Successful Enterprise Of The Year ’19
The award was given because we have shown continues growth for the past 5 years. This has only been possible because of our loyal customers – in both North America and Europe. Thank you for your support! We promise to keep doing our best to help you expand your business – by providing you with… Read whole story
Bioprocessing Summit: Time to rethink your HCP Coverage analysis?
Your HCP analysis should be both reactive to broader populations of HCPs and more specific to HCPs likely to be in the final product. However, with current methods, based on 2D PAGE and Western Blot, it is difficult to know if both of these conditions are met. If you’re in Boston today, you can experience… Read whole story