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Building Resiliency in Vaccine Development and Distribution

Vaccine manufacturers are relying on flexible and efficient ultra-low temperature processing and storage solutions to match the demand for vaccine production.

As vaccine manufacturers have had to rapidly ramp up production of medications to meet global demands, their requirements for precise refrigeration technology have also swelled. With a limited range of large-scale cooling technology available for the production process – including expensive freezer farms or large cold-rooms – biopharmaceutical companies were looking for more dynamic and scalable options. Watch how Merck met this need using Ultra Low Chamber cold storage systems by Farrar Scientific, a Trane Technologies brand, as they jumped in to produce the J&J Covid-19 vaccine.

It’s exciting to see industry giants collaborating and leading the way to redefine ultra-low temperature storage needs. I’m proud that our products are playing such a vital role,” said Holly Paeper, President Trane Technologies Life Science Solutions.

The Big Vaccine Pivot: Merck Falters on Covid-19 Shots, Then Makes One for Rival J&J - WSJ

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At this point right now we've just finished the filling process and that drug product is coming over to us in order to be packed out into a shipping configuration so that we can ship it to the downstream node. After Merck's two experimental vaccines failed in testing the drug maker decided to play a different role in the pandemic, helping rival Johnson and Johnson scale up its vaccine manufacturing efforts. That really created a nice opportunity for us to start a collaboration with Johnson and Johnson and be able to leverage their Covid vaccine product and be able to add capacity by leveraging our line and our team. Kim Dazura is the plant manager at Merck's vaccine manufacturing facility in West Point Pennsylvania. Her plant produces at least five hundred thousand doses of the Johnson and Johnson Covid vaccine every day and this month J and J released the first Merck made shots for distribution from Europe to other countries. We're right now on the manufacturing part of the campus and it has its own zip code it does it does have its own zip code. Public health experts consider the J and J vaccine key to protecting underserved communities around the world. The J and J vaccine only requires one dose and can be refrigerated unlike the Pfizer and Moderna vaccines which need to be stored at lower temperatures. So how did Merck's West Point plant prepare for this immense operation? We got an exclusive behind-the-scenes look at what it takes to manufacture the J and J vaccine. So what's actually happening here at this plant? The relationship between Johnson and Johnson and Merck have really two, two parts so we'll be manufacturing the drug substance part of the vaccine which is kind of the active ingredient of our vaccine products we'll be doing that in our Durham, North Carolina facility here at the West Point site we're responsible for the drug product. Desura says that after this facility receives the frozen drug substance from Johnson and Johnson the first step is to store it here in this freezer room. Trevor Brightwell is the Associate Director of Vaccine Operations at the West Point facility. What you see here is 18 minus seven ec freezers this is where the drug substance models will be stored upon receipt. Brightwell says these freezers are all new brought in specifically to store Covid vaccines and each freezer holds 5.5 million doses of the drug substance. Your typical freezer in your house might be running at -10 degrees C these are running at minus 70. Okay. So with these type of products the colder that you can keep it maintains the quality of the drug substance. When the drug substance is ready to be put in the vials it is moved to the filling facility. Here the drug is thawed and then sent to the filling line where exact volumes of the drug are dispensed into glass vials and individually capped and once they pass the automated inspection they are transferred to the pack-out room. So we're in the very final step of the process right before the product is about to go out the door. Because vaccines are a temperature sensitive product it's important to minimize their time out of refrigeration, so Merck developed this 3d printed tool to help workers pack vials as quickly and efficiently as possible. This tool grabs 39 vials in one go so workers don't have to load the vials one at a time. After the vials are ready to go they are shipped back to Johnson and Johnson to handle the final packaging and distribution. Preparing for this operation involved getting new equipment and modifying its filling line to accommodate the J and J vials, all of which Merck says it accomplished in less than a year. How long does it normally get ready to manufacture vaccines and do this process? Typically if we're bringing in a new product to a filling line it might take, you know, a year or two to be able to really go through all the qualification and and the transfer details. Part of the reason Merck says it was able to adapt in just a few months was its almost 60 years of vaccine manufacturing experience. We have a long history and a lot of different types of vaccine products including, you know, products that are pretty similar to the Johnson and Johnson product so it really helped us to be able to adapt our our current procedures quickly. Another reason is that Merck received help from the US government in March the Department of Health and Human Services said it would spend 105 million dollars to help Merck upgrade its facilities. A typical part for a filling line may take months to receive and we were able to turn that around in sometimes days and weeks. Desura says Merck plans to continue partnering with J and J until the pandemic ends or its manufacturing capabilities are no longer needed. I think all of us have been touched by the pandemic and so the ability to really contribute a potential solution for that is is just really remarkable.