Since she was a child, Therése Kallur has been interested in how the mind works. Today she makes spare parts for it.
“When I started studying psychology, I was deeply unsatisfied because I thought that we just brushed the surface,” she says. “That’s when I got interested in the brain, because that’s actually where the stuff happens.”
So she dug deeper, getting a degree in molecular biology and a doctorate in experimental neurology. She puts that education to use running business development for BioLamina, a Swedish biotech whose technology, among other things, helps replace dying neurons in patients suffering from Parkinson’s. The company does this by manufacturing a special type of protein that encourages pluripotent stem cells — basically blank-slate cells that can develop into any organ in the body — to turn into brain cells, heart cells, eye cells, and others. In May, BioLamina partnered with the Danish pharmaceutical company Novo Nordisk to help it develop stem-cell-based therapies for Parkinson’s and other diseases.
Turning a stem cell into a brain cell isn’t easy. The proprietary process developed at BioLamina involves building a special environment from the proteins, called laminins, so that they prompt stem cells to turn into the desired cells. Laminins are “like a canvas,” Kallur explains, “and the stem cells are the paint.” They engineer the proteins inside cells living in high-tech vats called bioreactors. Among many other factors, the biotech’s scientists must feed the cells, keep them warm, let them breathe and allow them to leave waste products when they grow in a bioreactor. “The cell nutrition, oxygen and temperature levels have to be exactly right — the tuning is a delicate process,” Kallur says.
BioLamina got the process down in a lab, but to go to market, the company needs to scale up. That’s why Kallur signed up to set up shop inside the Testa Center, a research facility that opened on Tuesday on the campus of GE Healthcare Life Sciences in Uppsala, Sweden. The center, funded jointly by GE and the Swedish government, will help companies like BioLamina develop and fine-tune their manufacturing processes so they can jump to large-volume production.
BioLamina will be the first company using the Testa Center, spending six months getting its production process ready. “We’re now in the perfect phase where we need some help to actually scale up,” Kallur says. “We will have our own staff at the Testa Center, and when they are fully trained we will bring everything over to our facility.”
Companies, institutes and universities can use the Testa Center services for as little as two weeks to as much as six months, like BioLamina.
GE and Sweden’s innovation agency decided to build the center two years ago. GE invested 4.5 million euros in the facility — supplying bioreactors and other technology and providing GE employees to staff it. The center will help the company to stay involved in the latest medical breakthroughs. “Innovation is the foundation of our business,” says Lotta Ljungqvist, the former head of research at GE Healthcare’s Life Sciences business and now GE’s CEO for the Nordics and Testa Center. “We need to understand what the small startups need because that will drive our business in a couple years.” She says that the resulting “flux of intangible knowledge” flowing through the Testa Center will allow GE to reduce its risk in developing new products and also give companies a safe space to test their production. “This is so needed.”
Sweden’s innovation agency, which invested 10 million euros in the project, is also looking at the big picture. The country has a long history of medical innovation. In the 1660s, the University of Uppsala — located across town from the GE campus — opened what was then only the second “anatomical theater” in the world, where students and professors could watch autopsies. Some may have been attended by Anders Celsius, an Uppsala native and the inventor of the Celsius scale, who taught astronomy at the university. Today the government wants to make it easier for medical startups and midsize businesses, as well as university researchers, to develop their ideas into viable businesses, just like their digital brethren Skype and Spotify.
BioLamina, for example, started nine years ago in the laboratory of Karl Tryggvason at the Karolinska Institute in Stockholm. Tryggvason, who spent his life researching laminins, launched the company with his son Kristian. Kallur, who joined in 2010, says the team initially worked one floor up from the elder Tryggvason’s office at Karolinska before moving to their own quarters. Over the years, they hired more scientists who helped them engineer a number of research-grade laminins that can turn stem cells into rods and cones for retinas damaged by macular degeneration, for example, cardiac muscle cells called myocytes for bad hearts, and dopaminergic neurons for brains afflicted by Parkinson’s. They sell the laminins to pharmaceutical companies.
“The demand for our high-quality laminins is growing and we need to scale up our capacity,” says Kristian Tryggvason, BioLamina’s CEO. “The Testa Center gives us a unique possibility to do this internally, instead of relying on large global contract manufacturers.”
The center, a brand-new two-story building comprising 27,000 square feet, includes four bioprocess laboratories and two common labs for preparation and analytics. The bioprocess labs — each the size of a large classroom — are designed to offer a standard production suite. They hold everything needed to run a bioproduction process from start to finish, including purified water, gases for cell culture and air locks for sterile work. If needed, the labs can also be upgraded to so-called biosafety level 2 standards, allowing companies to handle milder viruses like influenza. “The building mimics the real needs of the pharma industry,” says Jesper Hedberg, director of the Testa Center.
The Testa Center is open to any applicant. Besides companies working with stem cells like BioLamina and universities conducting education and general research, future users of the Testa Center will include vaccine developers and companies using viruses that reprogram white blood cells to help the immune system sniff out and kill cancer. Another focus will be the manufacturing technologies for producing biopharmaceuticals, the world’s fastest-growing class of medicines. These drugs include blockbusters like Humira, Remicade and Rituxan, which are designed to fight autoimmune diseases such as rheumatoid arthritis and psoriasis.
GE Healthcare’s Life Sciences unit in Sweden develops and manufactures different technologies and materials that drug companies use to mass-produce these medicines. “The last 10 years have seen a silent revolution in the pharma industry,” Hedberg says. “Biologics are molecules that are similar to those we have in our bodies. These drugs often have better specificity and smaller side effects and therefore work better, but their production is more complicated. This center will help companies, including GE, find new ways to make them faster and cheaper.”
As the engineering gets more precise, drug companies will be able to develop treatments for increasingly smaller groups of people, Hedberg says: “Many drugs won’t need to be produced on a huge scale anymore. The size of this facility will be a useful test the manufacturing process for many of these precision drugs.”
One way to do that involves GE’s single-use bioreactors, which allow companies to quickly switch production of one drug to another without the need for lengthy and laborious sterilization. Another approach involves digitization. Ljungqvist says the facility will enable GE to work with startups to gather data from sensors and use algorithms to monitor production. “When you make a drug, the process must be exactly the same every day for the next 30 years,” she says. “This need for high quality can be prohibitive to innovation. But today, you can use analytics to stay on top of the process and get the same quality and higher productivity at the same time.”
Ljungqvist says that she wants to establish a “digital foundation” for biomanufacturing. Ljungqvist and Hedberg say they need a “real, authentic environment” like the Testa Center to evaluate these digital tools and make sure they work — starting with monitoring equipment for vibrations, temperature fluctuations and other factors. She also wants to deploy technologies like virtual-reality goggles to speed up training and maintenance. “The single-use bioreactors use plastic bags and tubing, which allow us to avoid cleaning,” she says. “But workers need to make sure they install and connect them the right way. Every time you change them, you are basically building the whole production stream again.”
As for BioLamina, its team is busy building their proteins in the Testa Center. And Kallur is already thinking about future applications for the molecules, including using them to print tissues. “3D printing is so cool and it can be applicable,” she says. “Right now, it still needs some work. I’m not totally convinced that it could be used to replace whole body parts, but it could be useful for printing tissue for screening drugs.”
She’ll be able to hash these and other ideas out with fellow researchers, GE employees and visiting students during breaks at the Testa Center’s common cafeteria — which was designed to spur sharing and collaboration. Says Hedberg: “It’s a sandbox where they can play with the equipment and figure out the process.”