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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.
According to a new agreement between Mylan and Gilead, the former has the rights to manufacture and distribute remdesivir in 127 countries, a drug being tested to combat COVID-19.
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.
Experts from the US National Institutes of Health have written a commentary to promote a collaborative approach for the testing, scale-up and distribution of COVID-19 vaccine candidates.
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.
CEPI has announced that its funding for the Novavax COVID-19 vaccine candidate will go towards Phase I and Phase II trials as well as manufacturing costs.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
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.
CEPI has announced it is urging organisations to apply for funding for the development and manufacturing of potential COVID-19 vaccines.
The UK MRC and LifeArc are making £16 million available as grants to fund the establishment of Gene Therapy Innovation Hubs to improve resources for researchers and manufacturers.
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.
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
A new agreement between the University of Oxford and AstraZeneca will allow the former's COVID-19 vaccine candidate to be manufactured and distributed.
The World Health Organization (WHO) has launched its Access to COVID-19 Tools Accelerator, a collaboration to progress the development of coronavirus vaccines and therapeutics.
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
