Bioprocessing 4.0 can ease bottlenecks | Robot designed to ensure ultraclean production | COVID-19 challenges emphasize need for tech
July 9, 2020
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Process development and manufacturing
Bioprocessing 4.0 uses data to solve production problems and can be used to overcome bottlenecks in several areas. Before a company can adopt the approach, issues such as data collection, connectivity and analytics must be optimized; older equipment should be addressed; and upstream efficiencies must be matched with changes downstream to accommodate them.
Full Story: Genetic Engineering & Biotechnology News (7/6) 
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Facilities and equipment
Researchers at the Fraunhofer Institute for Process Engineering and Packaging IVV in Germany developed the Mobile Cleaning Device 4.0 robot, and one model cleans conveyor belts, while the other cleans walls, floors, ceilings and machines. The robot uses a sensor to detect contaminants and emits cleaning substances through its robotic arm, and self-learning and autonomous motility technology enable it to improve over time.
Full Story: New Atlas (7/2),  Food Manufacture (UK) (7/2) 
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Information systems
Regulatory obstacles, labor shortages and a risk of COVID-19 infection among workers at plants have slowed production for drug manufacturers. Technologies that address maintenance, digital review for batch records and employee infection screening can alleviate some of these challenges, say David Sprinzen, director of marketing for Vantiq, and Bryan Debois, director of industrial artificial intelligence for RoviSys.
Full Story: OutsourcingPharma (7/6) 
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Quality and regulatory issues
India-based Lupin Pharmaceuticals and Granules Pharmaceuticals have recalled their metformin products after the FDA warned that it discovered higher-than-acceptable levels of N-nitrosodimethylamine, a probable human carcinogen, in the drugs. Lupin is pulling all lots of its metformin extended-release tablets, while Granules is recalling 12 lots of tablets.
Full Story: Becker's Hospital Review (7/8) 
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Research and development
The NIH has announced the launch of a national clinical trials network, called the COVID-19 Prevention Trials Network, to help perform late-stage clinical trials of COVID-19 vaccines and other treatments. A vaccine co-developed by Moderna and the National Institute of Allergy and Infectious Diseases is expected to be tested in the first late-stage trial conducted through COVPN this summer.
Full Story: Regulatory Focus (7/8) 
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China has two COVID-19 vaccines slated to begin late-stage trials later this month, putting the country ahead of others in vaccine development. Eight of the 19 vaccines under development originate from China.
Full Story: Reuters (7/7) 
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No vaccine based on messenger RNA has been approved for use, but the technology has emerged as a leader for COVID-19 vaccines in what structural biologist Andrew Ward calls "the greatest science experiment in vaccinology." If successful, the vaccines are likelier to be easier to make and less expensive than conventional vaccines and could revolutionize vaccine development.
Full Story: The Washington Post (tiered subscription model) (7/5) 
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Gilead Sciences has begun evaluating an inhalable form of remdesivir for COVID-19 treatment that could be used outside hospital settings, launching early-stage testing in nearly 60 healthy adults. The company also intends to test remdesivir in combination with anti-inflammatory drugs.
Full Story: Reuters (7/8) 
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ISPE update
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and has been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results. Read More: Pharmaceutical Engineering®
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Published in the January/February 2019 issue of Pharmaceutical Engineering®, this article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The article was written by three ISPE Members that are experts in this area: James Canterbury, Steven Thompson, and Arthur Perez, PhD. Full Story: ISPE News
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