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Physicochemical failure modes for first-line therapy Narrow Therapeutic Index (NTI) drugs: a call for attention NTI risk classification and New Prior Knowledge

2 July 2021 | By , , ,

In this article, Dr Harsh Shah and colleagues summarise their research into the importance of characterising physicochemical characteristics that can result in stress-induced solid-state changes in Narrow Therapeutic Index (NTI) drugs.

Implementing the FAIR data principles is now a critical endeavour

29 June 2021 | By ,

With companies acknowledging the value of their data, it becomes increasingly important that data integrity be assured – and data stewardship implemented. In this article, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance explain the importance of the FAIR (Findable, Accessible, Interoperable, Reusable) data principles, factors…

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…

O-glycan analysis of therapeutic proteins enabled by O-glycoprotease

29 June 2021 | By , ,

Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…