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article

What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?

29 June 2021 | By ,

In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…

article

European Pharmaceutical Review Issue 3 2021

23 June 2021 | By

In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…

webinar

Quality assurance and data integrity from an auditors’ viewpoint

21 May 2021 | By Thermo Fisher Scientific

In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.