Pharmaceutical companies rushing to develop coronovirus vaccines are already working behind the scenes to build the supply chain needed to deliver their medicines to billions of people.
To meet global demand once the vaccine is approved, a complex and high-end supply chain will kick into gear on a scale that the pharmaceutical industry has rarely seen. Preparations include the lining of raw materials and factory capacity to manufacture vaccines on a large scale, and the equipment required to transport many millions of doses at once through distribution channels that will be subject to stringent safety and temperature control.
The magnitude and speed of effort creates the potential for gaps at each step that can cost invaluable doses.
The vaccine will likely be sent to hospitals, pharmacies, and central vaccination points, in the same way that medical teams have set up parking lots, schools and other sites to provide testing for the virus, the latest from Johns Hopkins University Count is infected. More than 16 million people and 661,000 people died worldwide.
Remo Collarso, a company owned by Johnson & Johnson and Johnson, which is on the verge of clinical trials for a potential vaccine, says “we have never done anything before on this scale”. .
The US government is joining, an allocation of $ 10 billion for Operation War Speed, an initiative that accelerates the development of vaccination with the aim of delivering 300 million doses of the coronovirus vaccine by January 2021. By comparison, drugmakers dose 174.5 million doses of the flu vaccine. Between last September and February in the US, according to the Centers for Disease Control and Prevention.
Lawmakers are considering a plan to step up the vaccine effort with an additional $ 25 billion. “Once a vaccine is successfully developed, how do you get all the production you need, and how do you get it? This is a role we are clearly playing a role in, ”said Senate Majority Leader Mitch McConnell (R, Ky.) Ahead of talks in Congress in July for the next round of coronovirus assistance.
Developers in many countries are reporting this as progress.
Three vaccine initiatives — University of Oxford and University of AstraZeneca PLC; Pfizer Inc.
And its German partner BioNTech SE; And CanSino Biologics of China — all said that their shots last week evoked immune responses and generally appeared safe to use. According to the WHO, earlier this week, there were 25 potential vaccines in clinical evaluation and 139 in pre-evaluation.
Noise to manufacturing, distribution channels
Some of the companies involved are building this supply chain for the first time.
10 year old Cambridge, Mass. Earlier this week based company said it had begun testing the final stage of a vaccine, never having sold the product on the market. Neither is novavax Inc.
A Gaithersburg, Md.-based drug developer who was awarded the largest federal grant to manufacture the vaccine to date.
“Just because Novavax has yet to market a product, it doesn’t mean we don’t have teams of people who have the experience and the ability to do so,” John Trizino, Executive Vice President, Chief Business Officer And Chief Financial Officer at Novax, which hired a manufacturing chief in June. Modern did not respond to requests for comment.
Experienced drug makers say they are moving to shore up their existing processes for manufacturing and shipping pharmaceuticals.
“Just every day, [we are] Trying to do the things that we usually do in a year, do them in months. Do things that usually happen in months, in days, ”said Pamela Civic as vice president of a division in global supply at Pfizer Inc., which is developing vaccine candidates with BioNotech.
Pharmaceutical companies are known as the primary vaccine component of the drug.
Jammu and Kashmir is developing a vaccine that uses a dormant cold virus to deliver a portion of the drug. To build it, the company plans to use the same type of bioreactors it used to make the Ebola vaccine, which received significant regulatory approval in Europe this month, but on a 90-fold scale, Mr. Collarso said .
Other companies, including Modern and Pfizer, are developing a new type of vaccine that distributes mRNA, a type of genetic material. Making this drug in bulk will require smaller devices than other methods, Ms. Civic said. He said that a unique process is required to make the drug, so Pfizer is designing new machinery with its vendors and modifying its plants to install the equipment needed for the job.
J&J has entered into deals with US contract pharmaceutical manufacturers Emergent Biosolutions Inc.
And catalyst Inc.
And plans to expand manufacturing to Europe and Asia. Mr. Colarusso said that for the first time the company would make a drug together at sites around the world.
Once they produce the last liquid vaccine, pharmaceutical companies will have to fill the vials with it, which will lead to another obstacle in delivery.
Medical glass supplies have been in short supply before the epidemic, when China began to require containers for long-term storage of pharmaceutical products, and this shortage has worsened. In June, the US awarded glass product manufacturer Corning Inc.
$ 204 million to expand manufacturing capacity and produce vials for coronavirus vaccines.
Jammu and Kashmir alone has purchased 250 million vials, the WSJ has already reported. Pfizer quickly went to its suppliers to secure the container, Ms. Civic said.
After the drug manufacturers fill the vials, the drug dealers will turn to experienced logistics providers to direct them to distributors or directly to medical providers.
Shipping capacity in question
Logistics operators can be another speed bump. They have struggled at times during demand upsets – particularly for consumer products and medical gear – leaving companies to find warehousing and transportation locations. The ability of the airfreight, which will be critical to moving a vaccine early in delivery, has been hit particularly hard because thousands of passenger flights – which carry cargo as well as cargo – have been grounded since the epidemic began. On the level.
“The logistics industry has nothing substantial — air capacity, ground handling personnel, specialized equipment — to handle it,” Neil Jones Shah, executive vice president and global head of airfreight at Flexport, a freight-forwarding company.
“No company can own an end-to-end vaccine supply chain. Cooperation will be important, ”Mr. Shah said.
During transportation, pharmaceutical companies and logistics providers will need to ensure that the dose is kept in a very tight temperature range to prevent the vaccine from becoming ineffective. The use of specific refrigerated containers and handling procedures is required at all times.
Drug manufacturers also require contingency plans in the event that all preparations are completed.
“There is a storm, the plane does not get off the ground, becoming involved in an accident,” said Mark Capofari, supply chain management lecturer at Penn State Leh Valley. “What plans do we have for shelving that product?”
William McAlory, an associate professor of supply-chain management at Rutgers Business School, said drug makers would also need to take action against criminal groups targeting high-value pharmaceutical goods.
Finally, companies have to be prepared to accommodate any part of the manufacturing and distribution process as scientists track reactions to a vaccine – a process that will be seen as closely as the development of the drug, Mr. McClory he said.
“The supply chain is going to be on its toes,” he said.
Write Elaine Chen at [email protected]
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