news
Emergent to assist in production of US COVID-19 vaccine candidates
The company announces it has been task ordered by BARDA to assist in the US government’s efforts to deliver COVID-19 vaccines.
List view / Grid view
Manufacturing
news
CDMO delivers 4,000 doses of COVID-19 vaccine candidate for Phase II/III trial
Advent announced it has manufactured and delivered the first 4,000 doses of the AZD1222 vaccine candidate for the University of Oxford clinical trial.
whitepaper
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon, and conductivity data
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
news
Operation Warp Speed: developing, manufacturing and distributing COVID-19 medical countermeasures
Exploring Operation Warp Speed, the Trump Administration’s program to expedite R&D, manufacturing and distribution of medical countermeasures for COVID-19.
article
Demand for synthesised drugs to drive growth of global drug intermediates market
Smita Deshmukh describes the current state of the global drug intermediates market, while suggesting how it will grow in the future.
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.
video
On-demand webinar: Managing your pharmaceutical quality system with 50 percent fewer staff
In this webinar, Lynne Byers explains how you can continue to keep your manufacturing site operating compliantly with significantly less staff.
news
Most UK adults believe COVID-19 vaccines and treatments should be distributed globally
A survey has revealed that the majority of adults in the UK believe governments need to work together to develop COVID-19 vaccines and treatments, which if effective, should be used worldwide.
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.
news
Mylan partners with Gilead to manufacture remdesivir, potential COVID-19 treatment
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.
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
Scientific leaders call for harmonised COVID-19 vaccine R&D
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.
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.
news
Programme to develop sustainable cold chain delivery for COVID-19 vaccine initiated
Researchers have begun research to find how sustainable cold chain delivery systems for a COVID-19 vaccine can be established in resource-poor countries.
news
CEPI invests $384m in Novavax COVID-19 vaccine candidate
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.
