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.
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.
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.
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.
Emergent BioSolutions and the Mount Sinai Health System have entered a partnership to develop an antibody from the plasma of people who have recovered from COVID-19. The US has provided $34.6 million for the study.
The Trump administration's Operation Warp Speed initiative will purchase 100 million doses of a coronavirus vaccine being developed by Novavax for $1.6 billion should it prove to be effective based on clinical trial data. Operation Warp Speed has spent nearly $4 billion to support companies developing vaccines, including Moderna Therapeutics and British drugmaker AstraZeneca.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci said the US is still in the first wave of the COVID-19 pandemic, which has now killed over 130,000 Americans and infected nearly 3 million Americans. At least 32 states are seeing rising rates of new infections, while new cases are holding steady in 14 states and declining in four, and many states have established some type of requirement that people wear face masks.
Drug manufacturers should consider facility and process design principles that accelerate time to market and support regulatory compliance even while they are in the initial stages of development, writes Dan UpDyke of Rockwell Automation. Four factors -- a common network protocol, a standard and not customized equipment platform, automation of data collection and flexibility to scale up -- can alleviate challenges and make the most of single-use facilities in the future.
Drug manufacturers are developing vaccines and treatments for COVID-19 at a record pace, which presents challenges in designing and deploying data models. Experts should sift through the data to ensure the right information is relayed, rely on the right statistical approach, create models that are easy to understand and be able to explain outputs so the data is trusted, writes Matt Jones of Tessella.
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