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With those details set in stone, attention turned to conducting contamination prevention and process closure risk assessments. In short, this client wanted ultimate flexibility. They required high segregation, high containment, and unidirectional flow to support their projected high throughput. By the end of the kickoff discussions, it was clear the client needed a single-use, multimodal, multi-product facility to support viral vector, viral vaccine, and therapeutic protein process types using suspension culture. Then comes the real work – not getting distracted from it! For our team to have a solid foundation for design decision making, we held multiple workshops to nail down user requirements prior to starting the design process. Locking down decisionsĪt the beginning of any project, it’s essential to define the ultimate goal. Here’s what we learned along the way – and how we’ll be taking those lessons into our next projects. Nevertheless, warp speed stretched us to our limits as we navigated uncharted territory. To make all of this happen at warp speed, we used an integrated project delivery approach. One hundred new pieces of equipment were purchased and qualified. Eight bioreactor trains and associated purification equipment were installed. Starting with a warm shell, grey space was converted into GMP clean room space in just four months. By the time the facility started GMP manufacturing in the fall of 2020, the Army Corp of Engineers indicated the project achieved the highest labour density possible with 100,000 labor hours in 4 months all injury-free. It was also a sobering responsibility that came with the most aggressive timelines we’d ever encountered in our careers.
In July 2020, our half-finished project became part of the endeavor.īuilding a facility in time to manufacture COVID-19 vaccine candidates was a massively ambitious project. In March 2020, our team set about designing and building what our client wanted to be “the largest scale-out cell culture manufacturing facility in the US.” Two months later, the US government announced Operation Warp Speed (OWS) – a partnership amongst various components of the Department of Health and Human Services with the goal of delivering 300 million COVID-19 vaccine doses by January 2021.
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The omicron variant is behind much of the recent spread.įor the latest news, sign up for our free newsletter. Where do things stand? See the latest coronavirus numbers in the U.S. We’ve also created a guide to help you decide when to keep wearing face coverings.
#Operation warp speed vaccines how to
Guidance: CDC guidelines have been confusing - if you get covid, here’s how to tell when you’re no longer contagious. Here’s how vaccine efficacy could be affected by your prior infections and booster history.
#Operation warp speed vaccines series
An initial vaccine series for children under 5 became available this summer. The FDA has cleared updated coronavirus booster shots for children as young as 5. You’re eligible if it has been at least two months since your initial vaccine or your last booster. Vaccines: The CDC recommends that everyone age 12 and older get an updated coronavirus booster shot designed to target both the original virus and the omicron variant. Here’s what to know about it, and why vaccines may only offer limited protection. Variants: BA.5 is the most recent omicron subvariant, and it’s quickly become the dominant strain in the U.S. A new study on long covid suggests many people don’t fully recover even months after infection.
The latest: The CDC has loosened many of its recommendations for battling the coronavirus, a strategic shift that puts more of the onus on individuals to limit viral spread.
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