Inside BioNTech’s Factory Where Pfizer Vaccine Is Made

0

If you’ve been vaccinated for COVID-19, likelihood is fairly excessive that you simply’re benefiting from a product made by BioNTech. The German biotech firm, co-founded by a husband-and-wife group of scientists, developed the vaccine that turned not solely the primary to earn authorization within the U.S. for COVID-19 in December but additionally the primary ever based mostly on a brand new know-how involving the genetic materials mRNA.

In interviews in December and March, co-founders Ugur Sahin and Ozlem Tureci spoke about their whirlwind yr and their partnership with U.S. pharmaceutical firm Pfizer to check and manufacture the vaccine. Over three days in late March, in addition they opened up their new manufacturing plant to TIME for the primary step-by-step have a look at how their lifesaving, and probably pandemic-ending, vaccine is made.

The new BioNTech manufacturing facility is in a wooded valley in Marburg. Technicians working in one of many prep labs usually spot deer roaming within the close by forest.

Luca Locatelli for TIME

The machinery that acts as the heart of the vaccine-manufacturing facility, regulating the flow of gas, water, electricity, wastewater and more throughout the building in Marburg, where 400 employees working around the clock produce several million doses of the vaccine each week.

The equipment that acts as the guts of the vaccine-manufacturing facility, regulating the circulation of gasoline, water, electrical energy, wastewater and extra all through the constructing in Marburg, the place 400 workers working across the clock produce a number of million doses of the vaccine every week.

Luca Locatelli for TIME

As Quality Control Lab Manager, Witali Schmidt oversees the testing of all raw materials coming in, as well as the finished product going out.  The product produced here goes into the human body,  he says.  So it's very important that the quality is perfect, that the person only gets the vaccine and nothing besides that.

As Quality Control Lab Manager, Witali Schmidt oversees the testing of all uncooked supplies coming in, in addition to the completed product going out. “The product produced here goes into the human body,” he says. “So it’s very important that the quality is perfect, that the person only gets the vaccine and nothing besides that.”

Luca Locatelli for TIME

When Sahin learn a scientific paper in late January 2020 describing the primary recognized instances of COVID-19 in Wuhan, China, “it was very clear to me that this was not a local outbreak anymore,” he says. “And most likely the virus had already spread worldwide.”

He knew there was no time to waste. But BioNTech, based mostly in Mainz, was then primarily a cancer-vaccine firm; after greater than a decade of analysis and growth, the corporate had examined its mRNA-based most cancers vaccines in about 400 folks, with encouraging outcomes. They have been simply exploring the potential for creating vaccines in opposition to infectious ailments–particularly an mRNA-based vaccine in opposition to flu–when COVID-19 hit.

To keep it protected in the body, the mRNA is encased in a bubble of lipids through a process that uses pure, pressurized ethanol. Because ethanol is highly explosive, technicians must wear special static-free boots.

To maintain it protected within the physique, the mRNA is encased in a bubble of lipids by a course of that makes use of pure, pressurized ethanol. Because ethanol is very explosive, technicians should put on particular static-free boots.

Luca Locatelli for TIME

Operations at the Marburg production site never stop, not even at night.

Operations on the Marburg manufacturing website by no means cease, not even at evening.

Luca Locatelli for TIME

Sylvia Groeb works in the early stages of the process, encoding the mRNA that teaches human cells how to trigger the antibody response needed to combat the virus.

Sylvia Groeb works within the early levels of the method, encoding the mRNA that teaches human cells find out how to set off the antibody response wanted to fight the virus.

Luca Locatelli for TIME

“[Ugur] convinced all of us, including our board, colleagues and scientific teams, that this was now our calling and we have to follow this mission,” says Tureci. At an emergency assembly, Sahin urged a 40-member group to “move with the speed of light” towards the corporate’s new objective of creating a COVID-19 vaccine. The group, which grew to greater than 200, labored nights and thru holidays on Project Lightspeed, and after a number of weeks had produced 20 candidates. An unprecedented 4 confirmed promise in neutralizing the virus. “There was a clear message that this has to be the priority,” says Andreas Kuhn, senior vice chairman of RNA biochemistry and manufacturing at BioNTech. “Whatever you’re doing right now, kind of forget about it because this is the most important thing now.”

With so little identified concerning the new virus, the group turned to what was identified about two associated coronaviruses: SARS and MERS. Soon it had a 50,000-step course of for constructing an mRNA vaccine in opposition to the brand new coronavirus, SARS-CoV-2.

Before pivoting to the COVID-19 vaccine, BioNTech was largely focused on using the new mRNA technology to develop cancer vaccines.  What the success of the coronavirus vaccine has now shown is that mRNA is really a proven technology for infectious diseases,  says Andreas Kuhn, senior vice president of RNA biochemistry and manufacturing at BioNTech.  We haven't forgotten about the cancer patients—the cancer programs are still running as much as it's possible under the current circumstances. We will of course go back.  Kuhn was recently vaccinated.  It was the first time that I got a vaccine, or any kind of medication, where I was actually involved in making it,  he adds.  So that was really special.

Before pivoting to the COVID-19 vaccine, BioNTech was largely centered on utilizing the brand new mRNA know-how to develop most cancers vaccines. “What the success of the coronavirus vaccine has now shown is that mRNA is really a proven technology for infectious diseases,” says Andreas Kuhn, senior vice chairman of RNA biochemistry and manufacturing at BioNTech. “We haven’t forgotten about the cancer patients—the cancer programs are still running as much as it’s possible under the current circumstances. We will of course go back.” Kuhn was just lately vaccinated. “It was the first time that I got a vaccine, or any kind of medication, where I was actually involved in making it,” he provides. “So that was really special.”

Luca Locatelli for TIME

It begins in a 50-L stainless-steel tank that extra carefully resembles a beer keg than what you may think to be a part of a lifesaving bioreactor. Inside are fragments of mRNA coding for the SARS-CoV-2 spike protein, the Achilles’ heel of the virus that the vaccine will exploit. The total manufacturing course of occurs in a hermetically sealed system, with merchandise from every stage transported to the following through a community of clear plastic tubing.

Even so, simply to be secure, technicians routinely take a look at the air within the manufacturing rooms for any extraneous micro organism or pathogens, and people working with the vaccine commonly faucet every gloved finger onto petri dishes stuffed with agar that may tradition for any stray microbes that may have made their means into the ability.

From start to finish, the entire manufacturing process flows through hermetically sealed plastic tubing. After the vaccine is pumped into bulk packaging, the tubes are sealed, then cut, to finish the process.

From begin to end, all the manufacturing course of flows by hermetically sealed plastic tubing. After the vaccine is pumped into bulk packaging, the tubes are sealed, then reduce, to complete the method.

Luca Locatelli for TIME

Lab technician Nabil Jajila is responsible for moving the bags of finished vaccines in bulk to the pallets that will eventually be shipped to another facility for putting into vials.

Lab technician Nabil Jajila is chargeable for transferring the luggage of completed vaccines in bulk to the pallets that may ultimately be shipped to a different facility for placing into vials.

Luca Locatelli for TIME

Manufacturing the vaccine requires large amounts of raw material, technical equipment and sterile supplies. Most of it is stored on-site in Marburg—where warehouse operator Tolga Dik is shown—and delivered to the labs on an as-needed basis.

Manufacturing the vaccine requires giant quantities of uncooked materials, technical gear and sterile provides. Most of it’s saved on-site in Marburg—the place warehouse operator Tolga Dik is proven—and delivered to the labs on an as-needed foundation.

Luca Locatelli for TIME

Because mRNA is comparatively unstable, it wouldn’t survive in its uncooked type within the human physique. In order to maintain the mRNA protected, it’s encased in a fatty bubble utilizing pressurized ethanol–a extremely flammable substance. The course of occurs in considered one of six 50-L tanks, every in its personal sealed-off room. The few folks licensed to enterprise out and in of the rooms placed on particular static-free footwear to keep away from producing an unintentional friction spark that might set off an explosion. Five of the tanks are named for group members who have been instrumental in creating the method, and the sixth is called Margaret, after the U.Ok. grandmother who was the primary particular person to obtain the vaccine.

Once the ethanol has completed its job of making the mRNA-containing bubbles, it’s filtered out. The result’s then filtered a number of instances extra, ultimately ending up as a milky resolution that fills 10-L plastic baggage. That liquid is shunted to the so-called fill-and-finish section, the place it’s purified in tanks after which squirted into sterile vials–every containing as much as six doses–which might be shipped to clinics world wide.

Lukas Knof, manufacturing engineer at the fill-and-finish facility operated by Baxter International in Halle.  It makes me very proud to work on this product, to help the whole world,  Knof says.  My first day [working with the BioNTech vaccine], I was really nervous because I had the feeling that the whole world was watching. It was a big day. For Baxter, and for me.

Lukas Knof, manufacturing engineer on the fill-and-finish facility operated by Baxter International in Halle. “It makes me very proud to work on this product, to help the whole world,” Knof says. “My first day [working with the BioNTech vaccine], I was really nervous because I had the feeling that the whole world was watching. It was a big day. For Baxter, and for me.”

Luca Locatelli for TIME

At the fill-and-finish facility operated by Baxter in Halle, 120 miles north of Marburg, technicians monitor the washing and sterilization of the vials before they are filled with vaccine, then stoppered and sealed.

At the fill-and-finish facility operated by Baxter in Halle, 120 miles north of Marburg, technicians monitor the washing and sterilization of the vials earlier than they’re stuffed with vaccine, then stoppered and sealed.

Luca Locatelli for TIME

At the Baxter facility in Halle, 220 vials can be filled and capped every minute. Before they are labeled, the filled vials go through one final inspection.

At the Baxter facility in Halle, 220 vials will be crammed and capped each minute. Before they’re labeled, the crammed vials undergo one last inspection.

Luca Locatelli for TIME

BioNTech at present produces 8 million doses of its vaccine each three to seven days on the new Marburg facility that the corporate bought from Novartis final fall. (Many lab technicians, most of whom transferred to BioNTech, nonetheless put on their outdated lab coats with the Novartis emblem, as there hasn’t been time to order new ones.) Ultimately, the plant will churn out 1 billion doses a yr, and BioNTech is working with Pfizer, which oversaw the ultimate human testing that resulted within the vaccine’s authorization within the U.Ok., the U.S. and elsewhere, to ramp up manufacturing to provide the two.5 billion doses it dedicated to offering the world in 2021.

Both corporations are fast to level out that their work just isn’t completed. Sahin and his group are additionally keeping track of new variants of the virus beginning to take maintain world wide, and have already developed one other vaccine to focus on these viral variations, they usually plan to begin testing it quickly.

Once bottled, the Pfizer-BioNTech vaccine is stored at -82°C (-116°F) at a filling and labeling facility in Halle.

Once bottled, the Pfizer-BioNTech vaccine is saved at -82°C (-116°F) at a filling and labeling facility in Halle.

Luca Locatelli for TIME

With the success of the COVID-19 mRNA vaccine, Sahin and Tureci see mRNA know-how as enjoying a extra dominant position in treating different ailments as properly, and are getting ready to choose up the work on flu and most cancers vaccines that was interrupted by the pandemic. For now, the group is rightfully pleased with what it’s achieved in a really busy yr.

“This is a once-in-a-lifetime project,” says Alexander Muik, director of immunomodulators on the firm, who was concerned within the early levels of creating the vaccine. “Who can say that they’re part of the solution for a pandemic? Only a few people can say that.”

With reporting by Julia Zorthian/New York

This seems within the April 26, 2021 problem of TIME.

Contact us at letters@time.com.

FOLLOW us ON GOOGLE NEWS

 

Source

Leave a comment