Rentschler Biopharma SE
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Latest From Rentschler Biopharma SE
US FDA finds flawed data integrity, investigations, aseptic practices and more at range of foreign and domestic drug product manufacturing facilities, while a bankruptcy leads to a massive drug recall.
All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.
The Swiss major, which is already signed up to help produce Pfizer and BioNTech's COVID-19 vaccine, is offering its services to CureVac to produce its mRNA vaccine.
Russia is planning to register a second COVID-19 vaccine this month, while the UK is ramping up its manufacturing capacity for vaccines and therapeutics.
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