The province of North Kivu, in the northeast corner of the Democratic Republic of the Congo, has been ravaged by war for much of the last two decades. But this summer, the nearly 6 million people who live there had to fight a new kind of vicious enemy — Ebola. As of Aug. 8, the World Health Organization had received reports of 44 cases, 17 of them confirmed, of this rare but deadly hemorrhagic fever caused by the Ebola virus. Between 2014 and 2016, a large Ebola outbreak in West Africa killed more than 11,300 people, but doctors in North Kivu now have a new weapon on their side: a vaccine developed by the pharmaceutical company Merck and distributed by the nonprofit Gavi, the Vaccine Alliance.
This is a new kind of vaccine. Unlike those designed to fight the flu or chickenpox, which use either dead or weakened versions of the illness-causing germs to prime the body’s immune response, the Ebola vaccine is a so-called viral vector vaccine. Researchers bioengineer them by taking common, mostly harmless viruses and adding to them bits of DNA that encode proteins and antigens specific to Ebola. These components do not cause the disease, but train the body’s immune cells to immediately recognize the Ebola virus as a dangerous invader that must be killed when it shows up.
The process of designing and making viral vector vaccines is not easy, but the results can be powerful. Earlier this year, health workers gave 3,300 people the Ebola vaccine during an outbreak in a different part of the DRC. That outbreak lasted from April to July and claimed 33 lives — a number that might have been much higher without prompt pharmaceutical intervention. “Vaccines are an important tool in the fight against Ebola,” said Dr. Oly Ilunga Kalenga, the DRC’s minister of health. “This is why it has been a priority to move them rapidly into place to begin protecting our health workers and the affected population.”
Sharing that sense of urgency is Daria Donati, director of business development and innovation at GE Healthcare Life Sciences. She has been leading a team at the GE unit’s site in Uppsala, Sweden, that developed a new way to help biopharma companies quickly take new viral vaccines from their labs, boost their volume to large enough quantities so they can be tested and, if the results show promise, quickly proceed to full production.
“This is a very conservative type of industry that has been making some vaccines the same way for the last 40 years,” Donati says. Some vaccines, for example, are still grown in eggs. But today, new bioengineering technologies allow doctors to fight and prevent disease by tweaking the body’s immune responses. “Innovative vaccines are taking advantage of this trend,” Donati says.
The promise of viral vector vaccines is that they could completely change the way we fight diseases. “The interesting thing is that you can potentially vaccinate a person for many different diseases using the same vector carrier,” Donati says. “This is generating great expectations for disease control. It’s the first time in the history of vaccination that pharmaceutical companies can develop many different kinds of vaccines using the same platform in the form of viral vectors.”
Donati says that viral vectors used for vaccines can cause only mild coldlike symptoms, at worst, but their virulence — the ability to infect and spread inside the body — is key to the vaccine’s success. “They help our immune system to recognize the danger and then they induce an immune response,” she says.
The “platform” is a new iteration of GE’s modular “factory in a box” called KUBio. Biopharma companies can haul KUBio’s components by truck to wherever they need them, and start cranking out drugs in 20 months — the time it takes to get it up and running. The new version is called KUBio BSL2, for biosafety level 2, which is required for working with infectious material like viruses. “This level of safety helps reduce contamination risks for the people working there and for the environment,” says Johan Rosenquist, global operations director for KUBio.
They are several full-scale KUBios working around the world and helping pharma companies like Pfizer develop and manufacture biologics, a new and quickly growing class of drugs that includes blockbusters like Humira and Remicade. Unlike ibuprofen — with its simple chemical formula that holds just 33 atoms — biopharmaceuticals are made from complex biological structures like proteins or killed microorganisms, made of as many as millions of atoms. Viral vectors and vaccine manufacturing are now the latest application for KUBio.
The first KUBio, designed for manufacturing monoclonal antibodies, was born when Rosenquist and two colleagues drafted their idea on a piece of paper during a three-hour layover at the Rio de Janeiro airport in 2011. They were returning from a business trip where they’d run into the usual obstacles. As a manufacturer of bioreactors and other biopharma equipment, GE was keen on providing its equipment and solutions to pharma companies to help them make their latest next-generation drugs, like biologics. But progress would often slow when an engineering company tasked with designing the facility to house the equipment entered the talks. “Customers would engage in lengthy studies spending a lot of money, even millions, to investigate the feasibility of their expansion plan,” Donati says.
So in Rio, huddled over stale snacks in a rented conference room, Rosenquist and his partners started developing the first KUBio concept. GE would supply not only the bioprocessing technology but the full factory-in-a-box solution. “We can now go to the customers and from the first meeting be able to discuss how much the project is going to cost, when it is going to be delivered and what it will be able to do,” Donati says.
The GE design provides flexibility because the KUBio and KUBio BSL2 are built in a modular concept. For example, GE’s FlexFactory, the bio-manufacturing platform inside KUBio, uses bioreactors and other bioprocessing equipment are mainly based on single-use technologies.
This versatility comes in handy given that fewer than 10 percent of promising biopharmaceutical projects never become drugs, Donati says. At the same time, she says, the viral vector market is projected to grow between 16 and 19 percent by 2022, and could be worth close to $2 billion by 2025. “If a project fails in clinical development, with KUBio you can quickly turn around the manufacturing and focus on the [next project],” she says.