Whitepapers/App Notes/Posters
Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
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QA/QC
Whitepapers/App Notes/Posters
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.
news
Rabbit pyrogen test to be replaced by European Pharmacopoeia
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.
news
Understanding your cleanroom fungi is key, says expert
New data shows that the majority of fungal genera isolated from a GMP cleanroom are filamentous and likely transferred into the facility from outside.
news
Global sterilisation monitoring market to value $913mn by 2027
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
article
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.
news
Pharmaceutical QC market to value $9,700mn by 2027
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
Whitepapers/App Notes/Posters
Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
article
Automating microbial methods for data integrity in the modern age
“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.
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Bioprocessing & Bioproduction In-Depth Focus 2021
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.
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Application Notes Supplement 2021
Here, industry experts share their research, guidance and pharmaceutical knowledge.
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What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
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…
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O-glycan analysis of therapeutic proteins enabled by O-glycoprotease
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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ICH M13: Bioequivalence guidelines
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.
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Enabling compliant data management with a comprehensive informatics solution
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.