Working in the biopharmaceuticals industry, Johan Rosenquist saw a problem. Biopharmaceuticals, also called biologics, are the world’s fastest-growing class of medicines, helping to fight against some of the world’s toughest diseases. They are protein-based drugs that are isolated from natural sources—mostly microorganisms like bacteria and mammalian cells.
The problem Johan saw was that biologics are typically expensive to make, in complex manufacturing facilities that take years to build, and are often prohibitively expensive for huge numbers of patients around the world.
Of the top ten therapeutics on the market today, seven are biopharmaceuticals, and these drugs are about to become even more commonplace — more than 5,000 biologic drug candidate products are in research and development. The global market for these medicines is more than $170 billion and is growing fifteen to eighteen percent annually. Biologics include synthetic insulin as well as medicines that battle rheumatoid arthritis, cancer and other diseases.
“When I joined Enterprise Solutions in 2009, I saw that the team was working on some really exciting things,” Johan remembers. “First there was an idea floating around, about fitting a biopharma factory into a truck that could be mobile, agile, and flexible enough to bypass many of the obstacles that face traditional manufacturing methods. We knew that we wanted to create a solution where the design starts from the actual production process and then we would create the facility around it, optimizing the production.”
Johan and his colleagues started refining this idea and finally got everything down on paper in their meeting in Rio de Janeiro. Four central principles guided them in their work: flexibility, short time-to-production, ensured global regulatory compliance and known and fixed investment from the start. They found someone who could help them build a standardized, modular facility that would be easy to put together and could be set up anywhere. KUBio™ was launched a year later.
KUBio™ is the factory-in-a-box with a complete turnkey approach, including construction and transportation to a customer’s site, manufacturing process optimization, validation of the facility and training of customers’ manufacturing professionals that solve many of the problems Johan saw in biopharmaceutical manufacturing.
The pre-fabricated facility arrives in modules that are 80 to 90 percent pre-equipped; units include heating, ventilation and air handling systems, clean rooms, most of the utility equipment and all of the technical installations and piping needed to run the plant, as well as the actual production platform for biopharmaceuticals, FlexFactory.
“There are several benefits to this approach to making biologics,” said Johan. “The setup time is short, project execution time is short, and customers can come into the market faster, making KUBio ideal also for smaller companies and startups.”
KUBio is being seen as a way to open up the biologics market to the world. In just a few years, the modular pre-fab facility has gone from an idea to a fully functional production facility in China, and will be included in a groundbreaking biotechnology center, also in China. Talks are underway for opportunities in such countries as Brazil, Mexico, South Korea and Saudi Arabia, among other places.
“There is huge potential, still, in this field, to help people,” Johan added. “Cancer, for instance, is a major worldwide disease… but in biopharma today we have the potential to create something that could cure people. KUBio, I hope, will make these new developments more accessible to those who need them most.”