Vaccine makers face biggest medical manufacturing challenge in history

By Julie Steenhuysen and Kate Kelland
CHICAGO / LONDON (Reuters) - It will be difficult to develop a COVID-19 vaccine in record time. It will be the greatest achievement in medical manufacturing in history to produce enough to end the pandemic.
This work is underway.
According to Reuters interviews with more than a dozen vaccine developers and their supporters, the road from sending experts amid global travel restrictions to coping with extreme storage conditions to inventing new types of vials and syringes for billions of cans is fraught with hurdles.
Any problem in an untested supply chain that could span from Pune in India to Oxford and Baltimore in the United States could torpedo or delay the complex process.
Col. Nelson Michael, director of the U.S. Army's Infectious Disease Research Center, which is working on the government's Warp Speed ​​project to deliver a large-scale vaccine by January, said companies typically have years to address this problem to solve.
"Now they have weeks."
Much of the world's attention is focused on the scientific race to develop a vaccine. But behind the scenes, experts face a blatant reality: we may simply not have enough capacity to manufacture, pack and distribute billions of cans at the same time.
Corporations and governments are trying to scale up machines to address a critical shortage of automated filling and refining capacities - the final step in the manufacturing process, in which the vaccine is filled into vials or syringes, sealed, and packaged for shipping.
"This is the biggest logistical challenge the world has ever faced," said Toby Peters, engineering and technology expert at the University of Birmingham in Britain. "We could try to vaccinate 60% of the population."
Several developers, including the leader Moderna, are experimenting with new methods to reduce the extreme cold storage requirements for their vaccines, which currently need to be kept at minus 80 degrees Celsius (-112 Fahrenheit).
SiO2 Materials Science works on the production of vials that do not break in extremely cold temperatures.
Travel restrictions meanwhile pose more prosaic problems. Johnson & Johnson, which plans to begin clinical trials this summer, has sought to send its vaccine experts to oversee, for example, the start of manufacturing facilities.

"NEVER IN HISTORY"
By setting up massive clinical trials with 10,000 to 30,000 volunteers per vaccine, the scientists hope to get an answer in October as to whether a vaccine works. But even if they do, it is a tremendous challenge to produce in bulk, to get regulators to unsubscribe, and to pack billions of cans.
Seth Berkley, CEO of the GAVI Vaccine Alliance, said in reality that the world was unlikely to go from zero vaccines to sufficient doses for everyone.
"First of all, it's probably a tailor-made approach," he said in an interview. "In the first year, we want to distribute one to two billion vaccine doses to the world population."
J&J has made a $ 1 billion investment with the U.S. government to accelerate the development and production of its vaccine before it turns out to be working. Emergent Biosolutions and Catalent have been contracted to mass produce in the United States. Catalent will also do some filling and finishing work.
"Never before in history has so much vaccine been developed at the same time - so there is no capacity," said Paul Stoffels, scientific director at J & J, who sees filling capacity as the main limiting factor.
Emergent's Bayview, Maryland facility can accommodate four vaccines simultaneously using different production platforms and devices.
The facility was funded by the government in 2012 and includes single-use bioreactor devices with plastic bags instead of stainless steel fermentation devices that make it easy to switch from one vaccine to another.
This month, the company received an additional $ 628 million to make these four suites available to support all government-selected candidates, CEO Bob Kramer told Reuters.

BLOW-FILL-SEAL-REPEAT
Not only did Catalent, New Jersey, work with J&J last week, but also signed a contract with British drug maker AstraZeneca to provide vial filling and packaging services at its Anagni, Italy facility. It aims to process hundreds of millions of cans, starting in August 2020 and possibly by March 2022.
The company has ordered high-speed vial fillers to increase production at its Indiana facility. A further 300 employees will be hired there.
Michael Riley, North America's president of biologicals at Catalent, told Reuters that his biggest challenge was to compress the work, which usually takes years to months.
In addition, glass bottles are in short supply.
To save glass, companies plan to use larger vials of five to 20 cans. However, this poses new problems, e.g. B. Potential waste if not all doses are used before the vaccine spoils.
"The downside is that a doctor has to vaccinate 20 people within 24 hours of opening a vial," said Prashant Yadav, a global healthcare supply chain expert at the Center for Global Development in Washington.
As part of the same initiative, the U.S. Department of Health and Department of Defense have provided ApiJect Systems with up to $ 138 million to modernize its facilities to produce up to 100 million plastic pre-filled syringes by the end of the year this year and until to 600 million in 2021.
The company plans to use a technology called blow-fill-seal that blows plastic syringes, fills them with vaccine, and seals them in seconds. This requires approval from the Food and Drug Administration, CEO Jay Walker told Reuters.

BREAK THE COLD CHAIN
Meanwhile, SiO2 Materials Science increases the capacity of plastic bottles with a glass liner that is more stable at extremely low temperatures.
"You can lower us to minus 196 degrees Celsius, which none of the vaccines require," said Lawrence Ganti, chief business officer. "You can throw it against the wall and it won't break. Our founder did that. He threw frozen bottles on me."
The company expects to increase production from currently 5 to 10 million vials a year to 120 million within three and a half months, he told Reuters.
Once packaged, many vaccines need to be kept cold - and some leading competitors in genetic material such as messenger RNA must be kept very cold - which is another challenge that can restrict access.
"People who work with mRNA store them at minus 80 degrees Celsius, which is not the case in most pharmacies or doctor's offices," said Dr. Paul Offit, director of the Philadelphia Children's Hospital Vaccine Education Center and co-inventor of the rotavirus vaccine.
Peters from the University of Birmingham has collected data from poorer regions of Africa and Asia and said that breaks in the temperature-controlled supply chain - "cold chain" - are already common.
In some countries, it's common to lose 25% or more of broken cold chain vaccines, he told Reuters.
"So if you want to make four billion and lose 25%, you have to make five billion," he said. "It's all elements to get it from the manufacturing site to the aggregation point, down to the health centers, and then to the community."

QUARANTINE QUAGMIRE
Companies developing mRNA vaccines, including Moderna and Translate Bio, who work with Sanofi, are working to make candidates stable at higher temperatures.
Ron Renaud, CEO of Translate Bio, said he was confident that this would happen "in a short time".
Colleen Hussey, a spokeswoman for Moderna, said: "We are more confident that we can operate our supply chain at -20 ° C, which is a simpler storage condition than freezing," she said.
Moderna plans to add a short period of time during which the vaccine can be stored in doctor's offices or clinics at normal refrigerator temperatures of 2 to 8 degrees Celsius.
"We'll know more in the next 2-3 months," she said.
The pandemic is also less of a technical obstacle.
Catalent, which has around 30 plants worldwide, had to write special permits in eight languages ​​to explain that its employees are considered essential.
J&J is having trouble moving experienced personnel to distant laboratories to monitor technology transfers to contract manufacturers as they are subject to a 14-day quarantine.
"It is absolutely a factor," said Stoffels. "If you have to send your people to the middle of India to fill the capacities, it's not easy at the moment."

(Reporting by Julie Steenhuysen in Chicago and Kate Kelland in London; writing by Josephine Mason; editing by Pravin Char)

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