Upcoming Events
3rd Annual MarketsandMarkets Cell & Gene Therapy Manufacturing Virtual Conference
Virtual ConferenceAttend Ejvind Mortz presentation on Day 1 of the conference program.
Passed Events
Moving SWATH LC-MS Host Cell Protein analysis into a GMP environment?
WebinarIn this webinar, you will learn about the possibility of GMP method transfer for HCP assays leveraging a robust and automated workflow based on combining data-dependent and SWATH mass spectrometry. Data from multiple projects over a period of 3 years were investigated to demonstrate the robustness and reproducibility of the method. Key Learning Objectives:… Read whole story
Webinar: How to monitor impurities and ensure consistent gene therapies
3.30pm BST | 7.30am PDT | 10.30am EDTThe Food and Drug Administration (FDA) is increasingly requesting cell and gene therapy developers to measure the characteristics of their complex products. However, many CMC managers cannot find a suitable commercial HCP ELISA. And the short project timelines do not allow for the development of a process-specific ELISA. Thus, many look for orthogonal HCP methods…. Read whole story
Why do we need orthogonal HCP analysis for mAbs?
LivestreamIs the “needle in the haystack” ruining your mAb product? Determining the HCP amount to a sparse sum using ELISA does not rule out that the product may contain ‘problematic’ HCPs – that may degrade the product or alter the function. Join our Livestream on July 6 to learn why you need an orthogonal method… Read whole story
Webinar: Moving LC-MS HCP analysis into a GMP environment
WebinarIn this 30 minute webinar with Thomas Kofoed, Co-founder of Alphalyse, you will get: An overview of the parameters that influence the reproducibility of mass spectrometry data Insights on how we have optimized the technology to manage and track variability A study of the reproducibility of mass spectrometry data across projects and time Example of a client method qualification, included… Read whole story
BEBPA 2021 Virtual Host Cell Protein conference
VirtualAlphalyse has again been invited to talk at the HCP symposium, on May 17-19, 2021. The BEBPA HCP Scientific Committee has been working diligently on the agenda. Here is a preview of the topics, talks and symposium structure planned so far: Topics • HCP ELISA Development and Lifecycle Management • High-Throughput HCP Analysis • Individual… Read whole story
Webinar: HCP analysis by Mass Spectrometry for Process Development
WebinarHow can you easily monitor all process-related impurities in your purification process? With the right tool, you can avoid time consuming purification matrixes and projects delays. Join us for a 30-minute webinar where we quickly explain the method that we have used in more than 100 client projects. Sign up here >>
Comparison of HCP profiles in monoclonal antibodies
WebinarHow many protein impurities are present in antibody pharmaceuticals – and should we be concerned? Alphalyse just completed a study of 58 mAbs using the most advanced LC-MS technology for Host Cell Protein analysis, performed in collaboration with Evidentic GmbH. Join us December 2 when Rikke Lund presents the findings. Sign up here → How do… Read whole story
4th Annual Bioprocessing of Advanced Cellular Therapies-VIRTUAL 2020
Virtual conferenceThe 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies Congress will be focusing on the manufacturing, process development, regulatory aspects of cell therapies and gene therapies. The special impact would be laid on, gene delivery based therapies, car-T cell-based immunotherapies, automated manufacturing, allogenic therapies, with the aspects of hurdles in supply chain management and… Read whole story