Latest news about Host Cell Protein

22 November 2022

ZenoTOF 7600 System installed

One challenge when developing next-gen biotherapeutics is identifying and eliminating undesired post-translational modifications (PTMs). PTMs can occur if biotherapeutic proteins are inadvertently exposed to stressors such as suboptimal pH values or temperature changes. Traditional methods for peptide mapping used in the development, characterization, and quality control of biotherapeutics hold several limitations. Particularly regarding detailed analysis… Read whole story

3 November 2022

PRESS RELEASE: World’s 1st MS-based HCP analysis under GMP for release test applied to Bavarian Nordic COVID-19 candidate

Alphalyse and Bavarian Nordic A/S significantly shorten the time necessary to document HCP impurities in COVID-19 vaccine candidate for Phase 3 clinical trial – through the world’s first MS-based HCP analysis under GMP conditions ODENSE, Denmark, November 3, 2022 –Alphalyse has performed the world’s first GMP-certified mass spectrometry (MS)-based Host Cell Protein (HCP) analysis for… Read whole story

13 June 2022

Webinar: Analyzing vaccine purity – without an HCP ELISA

Is your viral vaccine pure and consistent? One of the biggest challenges in developing viral vaccines is ensuring and documenting that the downstream process consistently produces a safe product – with low Host Cell Proteins (HCPs) levels. Join Ejvind Mortz on June 29: Learn how one LC-MS assay identifies and quantifies all proteins in the… Read whole story

31 May 2022

Summary of BEBPA’s 10th annual Host Cell Protein Conference 2022

Review of BEBPA HCP conference 2021 >>Review of BEBPA HCP conference 2020 >> June 2022 By Thomas Kofoed, Rikke Lund and Ejvind Mørtz, Alphalyse On May 16-19, we attended BEBPA’s annual HCP conference. The organizing committee had prepared an exciting conference program. It consisted of high-level scientific talks, audience poll questions, and panel discussions on… Read whole story

19 May 2022

The world’s first GMP-certified MS-based HCP analysis is now a reality

If you cannot get an ELISA to work, you can rely on MS analysis under GMP conditions. Last week, Alphalyse received our GMP certificate, officially stating that we are approved for performing quality control of biological API. So now we can set up validated mass spectrometry assays for analyzing residual impurities / Host Cell Proteins, using our… Read whole story

28 February 2022

Alphalyse and BioGenes collaborate on delivering HCP coverage analysis

Current guidelines recommend using several orthogonal methods to determine your ELISA’s coverage of host cell protein (HCP). Now Alphalyse and Biogenes pool our know-how and 20 years of experience in the HCP field for the combined use of our respective methods. We thus offer several HCP coverage methods: LC-MS-based coverage analysis (ELISA-MS™), Immunoaffinity Chromatography IAC… Read whole story

7 January 2022

Live30: Monitoring protein impurities to ensure consistent C&GT products

[Cell/Gene therapy] Are you prepared for FDA’s impurity concerns? 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? Join Ejvind Mørtz for an exploration of the 𝐥𝐢𝐦𝐢𝐭𝐚𝐭𝐢𝐨𝐧𝐬 𝐨𝐟 𝐭𝐫𝐚𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐦𝐞𝐭𝐡𝐨𝐝𝐬 (𝐞𝐠. 𝐄𝐋𝐈𝐒𝐀, 𝐒𝐃𝐒 𝐏𝐀𝐆𝐄, 𝐖𝐞𝐬𝐭𝐞𝐫𝐧 𝐛𝐥𝐨𝐭𝐭𝐢𝐧𝐠) for monitoring of… Read whole story

10 December 2021

HCP-MS analysis soon available as a release assay

Today, we submit our application for manufacturing authorization to the health authorities, soon enabling us to perform quality control of active pharmaceutical ingredients according to EU and US GMP. The submission concludes a three-year investigation of our mass spectrometry-based Host Cell Protein analysis (HCP-MS) method’s robustness and reproducibility across more than 200 projects. Common for all projects is… Read whole story

18 November 2021

New coverage webinar with Ejvind Mortz

In just 30 minutes, you can learn how to use ELISA-MS™ coverage analysis to: a) Make ELISA kit bridging studies – when your supplier switches to a new batch of capture and detection antibodies b) Check if the coverage of your ELISA is good enough – especially for uncommon expression systems c) Select the ELISA… Read whole story

14 October 2021

Article: Monitoring process-related impurities in biologics

Get free access to our latest publication on HCP analysis by LC-MS and ELISA with data from PPQ runs and regulatory license applications. https://www.alphalyse.com/customer-support/publications-references/article-monitoring-impurities/ Lead authors: Katrine Pilely and Martin Rask Johansen.

21 September 2021

Webinar: How to monitor impurities and ensure consistent gene therapies

It can be challenging to find a suitable commercial ELISA to monitor the process-related impurities in cell and gene therapies. E.g., due to the use of a novel cell line because there are impurities from multiple organisms. On October 5, Ejvind Mortz shows how Mass spectrometry (LC-MS) provides unrivaled HCP quantification and high reproducibility of… Read whole story

16 August 2021

Alphalyse expands the impurity analysis team

To keep up with the growth in impurity analysis, we have hired two new experienced PhD-level scientists for our team; Rie Bak Jäpelt and Anette Holck Draborg. Rie brings immense experience in mass spectrometry method development and validation, especially for quantitative analysis.She also holds strong qualifications within quality control of analytical methods.For more than 10 years, Rie has… Read whole story

1 July 2021

Webinar: Why do we need orthogonal HCP methods for mAbs?

💠 Why:Monoclonal antibody products (mAbs) are often relatively pure due to the efficient removal of host cell proteins (HCPs) using protein A purification and the following polishing steps. However, determining the HCP amount to a sparse sum does not rule out that the product may contain ‘problematic’ HCPs at low – but still critical –… Read whole story

4 June 2021

Review of BEBPA’s HCP Conference 2021
Key topics & take-home messages

Review of BEBPA HCP conference 2022 >>Review of BEBPA HCP conference 2020 >>Review of BEBPA HCP conference 2019 >> May 2021, by Rikke Raaen Lund and Thomas Kofoed, Alphalyse BEBPA’s 9th annual Host Cell Protein Conference took place, again as a virtual conference, on May 17-19, 2021. The BEBPA organizing committee once again assembled an exciting… Read whole story

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

31 October 2020

Review of BEBPA’s HCP Conference 2020
Key topics & take-home messages

Review of BEBPA HCP conference 2022 >>Review of BEBPA HCP conference 2021 >>Review of BEBPA HCP conference 2019 >> 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… Read whole story

23 July 2020

Research article published: Novel coverage method 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 the production of recombinant biopharmaceuticals… 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