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This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
A PricewaterhouseCoopers report has highlighted the directions that the growth of the contract development and manufacturing organisation (CDMO) outsourcing market will take in the near future.
The CDMO AMRI has said it will boost its production of the malaria drug hydroxychloroquine sulfate, identified as a potential COVID-19 treatment, following an emergency use authorisation from the FDA.
An outsourcing company has announced that Phase II, III and IV clinical trials of vaccines will continue at a growing number of sites, assessing the safety of each in light of COVID-19.
Following the initiation of a clinical trial, a COVID-19 vaccine candidate developed by UK researchers is being manufactured in several outsourced facilities.
A Contract Development and Manufacturing Organisation (CDMO) has been recognised in six different categories at the 2020 CMO Leadership Awards.
A letter from the CEO of Gilead reveals how the company plans to scale up production of remdesivir in light of the COVID-19 pandemic.
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
Within this issue are articles which investigate polyelectrolyte multilayers as drug carriers, discuss how developments in pharma impact logistics and examine how the industry can regulate heavy metals in medicinal cannabis. Other features include how to use the correct tablet tooling and trends for the CDMO sector this year.
7 February 2020 | By OSIsoft
Trustworthiness in data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational excellence, reporting or development. Hear the latest findings from OSIsoft’s research in our on-demand webinar.
