news
Report reveals CMOs in Italy concentrated in worst-hit COVID-19 regions
According to findings, the majority of CMOs in Italy are found in the locations hit worst by COVID-19, meaning the pharma supply chain has been greatly impacted.
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Outsourcing
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Four UK CROs announce collaboration to work on potential COVID-19 therapeutics
A group of four CROs at BioCity Nottingham have joined forces to collectively work on the research of COVID-19 therapies.
video
On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
whitepaper
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
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.
news
FDA new drug approvals down 16 percent in 2019, impacting outsourcing
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.
whitepaper
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
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).
article
The opportunities for CDMOs in the pharmaceutical industry
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.
news
CDMO pledges increased production of hydroxychloroquine sulfate, potential COVID-19 treatment
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.
news
UK vaccine clinical trial outsourcing expansion continues
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.
news
UK COVID-19 vaccine candidate to be manufactured at seven outsourced sites
Following the initiation of a clinical trial, a COVID-19 vaccine candidate developed by UK researchers is being manufactured in several outsourced facilities.
news
CDMO recognised in six outsourcing award categories
A Contract Development and Manufacturing Organisation (CDMO) has been recognised in six different categories at the 2020 CMO Leadership Awards.
news
Gilead aims to produce one million remdesivir treatment courses by 2021
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.
article
Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
article
Trends in the CDMO industry for 2020
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…
