Whitepaper: Learn about biofilm in hot WFI
This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
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This paper explores the presence of biofilm in hot WFI systems and the use of rapid microbial methods to overcome the limitations of plate counts.
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.
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.
Download this in-depth focus to discover why new licensing guidance could prompt a biosimilar boom in the UK and learn about recent developments in O-glycan analytical approaches for therapeutic proteins.
Here, industry experts share their research, guidance and pharmaceutical knowledge.
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…
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…