Alphalyse

𝗣𝗥𝗘𝗦𝗦 𝗥𝗘𝗟𝗘𝗔𝗦𝗘: 𝗔𝗹𝗽𝗵𝗮𝗹𝘆𝘀𝗲 𝗵𝗮𝘀 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗲𝗱 𝘁𝗵𝗲 𝘄𝗼𝗿𝗹𝗱’𝘀 𝗳𝗶𝗿𝘀𝘁 𝗠𝗦-𝗯𝗮𝘀𝗲𝗱 𝗛𝗖𝗣 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝘂𝗻𝗱𝗲𝗿 𝗚𝗠𝗣 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗿𝗲𝗹𝗲𝗮𝘀𝗲 𝘁𝗲𝘀𝘁 𝗼𝗳 𝗕𝗮𝘃𝗮𝗿𝗶𝗮𝗻 𝗡𝗼𝗿𝗱𝗶𝗰 𝗔/𝗦 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵 𝗯𝗼𝗼𝘀𝘁𝗲𝗿 𝘃𝗮𝗰𝗰𝗶𝗻𝗲 𝗰𝗮𝗻𝗱𝗶𝗱𝗮𝘁𝗲.

We proudly announce the successful performance of the world’s first GMP-certified mass spectrometry (MS)-based Host Cell Protein (HCP) analysis for product release testing for Phase 3 clinical trial.

The unique LC-MS-based HCP analysis developed by Alphalyse is significantly faster than traditional methods for product impurity documentation and has the potential to reduce the time required to document new vaccines, from the current industry standard of 12-18 months to as little as 4 months, while being as safe or safer than older methods.

This makes the Alphalyse method particularly useful for developing vaccines during a global pandemic when the time to create a process-specific ELISA is limited.


Read the full press release on our website: https://lnkd.in/eNJq5TPB

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 w...

"The 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.

Join Ejvind Mortz on October 5 to discover why the industry now turns to LC-MS analysis to characterize and monitor process-related impurities in cell and gene therapies.

Learn more → " https://www.alphalyse.com/customer-support/webinars/monitoring-impurities-gtp/

Great article on understanding HCP profiles and integrating effective removal strategies in development of new biological drugs.

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