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EMA begins rolling review of Novavax’s NVX-CoV2373 COVID-19 vaccine
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
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Drug Manufacturing
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UK Government orders 100 million doses of Valneva COVID-19 vaccine
The UK Government has ordered a further 40 million doses of Valneva’s COVID-19 vaccine candidate, to be manufactured in Scotland.
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Valneva begins manufacturing its inactivated, adjuvanted COVID-19 vaccine
The company announced that the Phase I/II trial for VLA2001 is now fully enrolled and that it has begun manufacturing the vaccine candidate on an industrial scale.
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Fire at Serum Institute of India, production site of COVID-19 vaccine
Reports have said five people have been killed in a fire at the Serum Institute of India, where the Oxford-AstraZeneca COVID-19 vaccine is being made.
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EC Pharma Strategy: the first steps towards a more sustainable industry?
Richard Daniell explains why Europe needs a strong pharmaceutical manufacturing base and supply chain to ensure a resilient network.
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Baxter BioPharma Solutions to manufacture Novavax’s COVID-19 vaccine
The agreement is expected to advance the commercial-scale manufacturing of the NVX-CoV2373 to enable it to be distributed across Europe following regulatory approval.
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Pharmaceutical bottle packaging – the quest for zero defects and data integrity
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
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Innovations in analytical science: development of rapid, high-throughput glycoanalytics for biopharmaceuticals
Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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Life sciences flow metrology challenges
To realise quality, yield and cost benefits, there is a clear need to develop expertise and capability in the flow measurement and characterisation of pharmaceutical powder and fluid flows within continuous manufacturing processes. Dr Tracy Brown from the TÜV SÜD National Engineering Laboratory in the UK has investigated potential flow…
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Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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Manufacturing, Packaging & Logistics In-Depth Focus 2020
Read this in-depth focus to develop your expertise in the characterisation of pharmaceutical powder and fluid flows during continuous manufacturing and find out the benefits of adopting high-resolution, cryogenically cooled thermal imaging for bottle packaging testing.
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Innovative filtration technologies to shoulder responsibility for pharmaceuticals
Akshita Pacholi outlines why the filtration market is so important to the pharmaceutical industry and discusses its predicted growth in the near future.
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Lonza’s MODA-EM™ Paperless Solution to be implemented at the UK’s New Vaccines Manufacturing and Innovation Centre
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) has selected Lonza’s MODA-EM™ Solution to digitise its Microbiology Quality Control operations. The MODA EM™ Platform will form a vital part of ongoing work that will support the VMIC coming online a year ahead of schedule.
