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On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
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Manufacturing
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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.
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CEPI calls for proposals to apply for COVID-19 vaccine funding
CEPI has announced it is urging organisations to apply for funding for the development and manufacturing of potential COVID-19 vaccines.
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MRC and LifeArc announce grants for Gene Therapy Innovation Hubs in UK
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.
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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.
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New standards to help remove foreign particles in bioprocessing
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
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FDA grants remdesivir emergency use authorisation to treat COVID-19
The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
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University of Oxford and AstraZeneca sign deal to produce COVID-19 vaccine
A new agreement between the University of Oxford and AstraZeneca will allow the former's COVID-19 vaccine candidate to be manufactured and distributed.
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Sartorius closes acquisition of selected assets of Danaher Life Sciences
Sartorius has announced the completed acquisition of some life science businesses of Danaher for a total of $825 million.
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WHO launches Access to COVID-19 Tools Accelerator
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.
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Utilising CRISPR could reduce contamination in recombinant-protein drugs
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.
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Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
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The quest for efficiency – moving towards continuous processing
There are many challenges faced by the biopharmaceutical industry in order to develop and provide sufficient drugs to treat a growing and ageing population. This article discusses whether continuous processing provides the solution.
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£14m funding to support rapid COVID-19 vaccine manufacturing scale up
The UK Bioindustry Association industry-led vaccine manufacturing group has welcomed a £14 million investment to support COVID-19 vaccine manufacturing.
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Under the microscope: Highly potent APIs and toxic payloads
Dr William Sanders discusses trends in the development and manufacture of highly potent active pharmaceutical ingredients (HPAPIs) and toxic payloads for antibody drug conjugates (ADCs).
