How 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
The 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
Meet us at BEBPA Host cell conference 26-28 October. Make sure to attend our virtual presentation on 27 October: HCP Profiling in Commercial mAbs and Biosimilars. Download conference brochure here: https://www.bebpa.org/brochures/2020-HCP-Current.pdf Update 31 October: Read a review of the virtual symposium here >>
As the leading laboratory in HCP analysis by mass spectrometry, Alphalyse will attend this year’s Analytica. Come discuss your challenges in host cell protein detection for process development – meet us at the Sciex booth. Will you be joining us there? Let us know if you’d like to meet. Email us Event site
When you submit an IND for a Cell or Gene Therapy product, guidelines state that you must measure process-related impurities in the drug substance and monitor process performance parameters for process consistency. Often there is no impurity ELISA available – or the host cell protein (HCP) coverage of the ELISA is low. So how do… Read whole story
Find out how 100+ biotechs speed up and improve on their process development – using this unique analysis • You will get examples of how an LC-MS based HCP assay can provide early detection of problematic HCPs. • We will go over a customer case where the analysis was used to optimize a 6-step purification process. • Learn how a customer… Read whole story
Our friends at SCIEX are conducting a series of online talks next week, featuring Alphalyse CEO Thomas Kofoed as one of the speakers. 6 Customers presenting for 3h on the characterization of complex ADCs, chromatography optimization, CRISPR technology, MAM and HCPs. See the video with Thomas Kofoed from Alphalyse to have an snapshot on what he will present on… Read whole story
Alphalyse will join the AGC Biologics 2020 Global CMO Consultant Summit in Barcelona. Contact us if you would like to talk to us about your Host Cell Protein projects.