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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…
Pharma 4.0 represents the next step in the evolution of pharmaceutical manufacturing, and is heralded as providing manufacturers with better efficiencies, higher output and quality, as well as flexible production. Here, Dr Saly Romero-Torres highlights some of the key trends in digital transformation and explains why a strong informatics infrastructure…
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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…
Graeme Duncan, CEO at ADVANZ PHARMA, discusses how targeted strategic investment within the off-patent sector can add value and enhance choice for patients and healthcare professionals alike, while helping to drive and maintain innovation within the pharmaceutical industry.
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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…
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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.
While we all know that COVID-19 has promoted growth in the vaccine contract manufacturing market, what other factors are impacting the field? In this article, EPR summarises the trends and opportunities identified by a new market research report.
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
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…
