Manufacturers work together on COVID-19 solutions | Stencil printing shows promise in drug manufacturing | AI can solve drug recall, shortage challenges
June 30, 2020
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Process development and manufacturing
Drug manufacturers and others in the health care industry and beyond are working together in new ways to support the fight against COVID-19. The US is working with private companies to expedite vaccine development, while some companies are joining together in large consortiums, such as a UK partnership created to manufacture 20,000 ventilators.
Full Story: European Pharmaceutical Review (UK) (6/25) 
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Facilities and equipment
A team at Abo Akademi University in Finland used stencil printing to make an orodispersible disc for administration of the antipsychotic haloperidol, and the technique could be used to manufacture other drugs in niche doses or formulations, writes Henrika Wickstrom, a researcher on the project. Stencil printing is similar to the technique used by children in art projects, and while simple, it presents challenges with ink formulations and drying times, Wickstrom writes.
Full Story: The Medicine Maker (registration required)/The Small Molecule Manufacturer (6/29) 
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Information systems
Artificial intelligence has myriad possibilities for pharmaceutical companies, such as predicting drug shortages and managing inventory, writes pharmacist Doug Zurawski, senior vice president of clinical strategy at Kit Check. Manufacturers can also zero in on the source of contamination leading to a drug recall, and they can use AI to locate and pull all recalled packages from the supply chain, Zurawski writes.
Full Story: Pharmacy Times online (6/26) 
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Supply chain management
Daiichi Sankyo hopes to bolster its supply of a COVID-19 vaccine through a deal with AstraZeneca. Daiichi would receive undiluted vaccine from that in development between AstraZeneca and the University of Oxford, and formulate and package it in Japan.
Full Story: Reuters (6/26) 
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More than 2 million US adults have purchased prescription drugs from other countries to save money, according to an analysis of 2015-2017 nationwide survey data. The study, reported in JAMA Network Open, found that immigrants and those who rely on the internet to get health care information were among those more likely to get prescription drugs from outside the US.
Full Story: HealthDay News (6/26) 
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Quality and regulatory issues
The FDA, the European Commission and the European Medicines Agency are working together to identify COVID-19 treatments and vaccines and are extending their collaboration to other regulators around the world through the International Coalition of Medicines Regulatory Authorities. Regulators are jointly determining data requirements for clinical trials by holding virtual meetings to expedite vaccine development.
Full Story: PharmExec (6/29) 
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Research and development
The COVID-19 vaccine candidate being developed by AstraZeneca has probably progressed the furthest, according to World Health Organization Chief Scientist Soumya Swaminathan, though it is followed closely by Moderna's candidate. Meanwhile, the ACT-Accelerator, a WHO-led coalition, is seeking funding from governments and donors from the private sector in a bid to raise $31.3 billion in the coming year for the development and delivery of COVID-19 vaccines, treatments and tests.
Full Story: Reuters (6/26) 
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The pending withdrawal of the US from the World Health Organization could leave it out of the loop when global health officials meet to decide what strains to include in the flu vaccine for upcoming influenza seasons. These meetings also cover animal viruses that could be looming threats, and Nancy Cox, who led the CDC's influenza division for 22 years, said the agency would be "flying blind."
Full Story: STAT (tiered subscription model) (6/29) 
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Vaxart will launch testing of its oral COVID-19 vaccine candidate in monkeys with novel coronavirus infections in a study backed by Operation Warp Speed, the vaccine-acceleration program of the Trump administration. The vaccine, which was developed in oral tablet form, will be easier to administer and store compared to its injectable counterparts, the company says.
Full Story: Reuters (6/26) 
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ISPE update
Visit ISPE's COVID-19 Resource Page to read the latest articles and view recordings of webinars by some of ISPE's expert Members, including our recent webinar "Creating a Vision of the Future - An Evolution or Revolution of the Pharmaceutical Supply Chain Panel and Fireside Chat." View More: ISPE
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There's sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation. Read More: iSpeak
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