Latest news about Host Cell Protein

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

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

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

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

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

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

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

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

12 September 2019

‘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 >>

6 September 2019

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

13 August 2019

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

4 June 2019

Review of BEBPA HCP Conference 2019 – Key topics & take-home messages

BEBPA’s 7th annual Host Cell Protein Conference May 15-17th took place in Los Angeles, California. It once again attracted HCP experts from biopharma, service- and technology providers, and regulatory agencies. The organizing committee had again put together a great mix of talks, workshops and round-table discussions. Very importantly, there was also plenty of time for… Read whole story

2 May 2019

Alphalyse scientist successfully defends PhD thesis

CONGRATULATIONS to Katrine Pilely who Tuesday successfully defended her PhD thesis at the University of Copenhagen. Under supervision of Professor Peter Garred, Katrine Pilely studied how cholesterol crystals activate the immune system. This happens through complement-mediated mechanisms, and therefore contribute to the pathophysiology of atherosclerosis. Katrine further showed how to inhibit the upstream cholesterol crystal-induced… Read whole story

22 February 2019

Easy method for following specific HCPs through purification steps

See how Rikke Lund’s team helps with removal of host cell protein contaminants from recombinant protein with the use of mass spectrometry. In this short video Rikke gives examples of customer results. The host cell protein analysis provides the customer with both identity and quantity of individual HCPs. This makes it possible to compare and identify differences… Read whole story

6 February 2019

Webinar: Don’t rely solely on ELISA 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

31 January 2019

Document residual protein A in final drug substance

Standard analyses do not detect trace amounts of protein process additives, otherwise known as residual proteins. Examples include growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, etc. Instead, you can now use a customized LC-MS assay developed by Alphalyse. It will detect residual proteins of interest – in both your final drug substance… Read whole story

3 January 2019

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

6 December 2018

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