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The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
Physicochemical failure modes for first-line therapy Narrow Therapeutic Index (NTI) drugs: a call for attention NTI risk classification and New Prior Knowledge
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.
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
“Continuous improvement” is a buzz phrase in the biopharmaceutical industry. Despite its reference in numerous regulatory and guidance documents, resistance to improvement remains strong in microbiological quality control.
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…
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…
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