Making biologic drugs — those grown from living cells — is an elaborate, slow process requiring giant equipment and lots of time. It is not mobile or flexible.
Now a team led by researchers at the Massachusetts Institute of Technology is trying to make the ultimate mobile drug lab, one that can be pieced together on a battlefield or brought to a clinic at the front to brew small batches of medicines in a day or less.
"If they are successful — and I believe they will be — it's going to be really a breakthrough," said Konstantin Konstantinov, vice president of late-stage process development at Genzyme Corp., who is not involved in the work. "It opens up many new possibilities that we have not seen before."
Funded by a $10 million grant from the Department of Defense, the research team's goal is to create a "tabletop" bioreactor — a sophisticated brewing system used to make biologic drugs — that could be deployed virtually anywhere. It should be able to make distinct batches of wound-healing drugs for soldiers on a battlefield or highly specialized therapy for a patient with a rare condition.
Biologic drugs are made from living cells. In this case, the researchers are "brewing" drugs from yeast, much like beer is brewed. Typically, a production line for biologics includes giant tanks ranging in size from 2,000 to 20,000 liters, and it can take a row of them to produce a batch of drugs. The process from start to finish can take six months or more.
Turning that into a mobile operation is a prodigious task. The process has to be shrunk by more than a thousandfold and sped up to work in less than 24 hours. And the drugs have to be tested in near-real time to prove they are safe, pure, and potent.
In addition to MIT's Center for Biomedical Innovation, the project includes researchers from Northeastern University, Rensselaer Polytechnic Institute, and industrial collaborators, such as Pall Corp., Perkin Elmer Inc., and Latham BioPharm Group.
The team has promised that the bioreactor will be able to produce two drugs within the next two years. If they meet that goal, the research will be eligible for a follow-up two-year grant to add four more drugs.
At its core, the bioreactor contains a device about the size of a cellphone for culturing cells that can produce the kinds of drugs now used to treat cancer, infections, and other diseases. Funneling the cells into tiny channels, along with nutrients and gases, allows researchers to monitor and optimize conditions for small-scale production.
"We tell them how often to eat, what to eat — and in return they make drugs," said project leader J. Christopher Love, an associate professor of chemical engineering at the Massachusetts Institute of Technology's Koch Institute.
The biggest innovation of all will come with the yeast used to produce the drugs. Researchers will have to tinker with the yeast's genetic code to encourage each cell to produce a larger amount of medicine.
"It's not the natural behavior of these organisms to produce tons and tons of drugs," said Timothy Lu, an assistant professor at MIT who is working on the genetic engineering aspects of the project.
Normally, the yeast produces only one kind of protein, but by changing the genetic code Lu said he expects to be able to get the yeast to produce multiple drugs.
The rest of the bioreactor, which is comparable in size to a six-pack of long-neck beers, now contains small bottles of food and water to provide nutrients to the yeast. Most of the system will consist of inexpensive "plug-and-play" pieces that can be easily scaled for different uses, Love said.
The aim is not to replace commercial production, Love said, but to address different needs. Just as 3-D printing is creating new production practices, but not replacing factories, the new bioreactor could take drug manufacturing in new directions, Love said.
The device is "a supplement to provide new opportunities to distribute manufacturing, to improve access to drugs, to provide new drugs, and ultimately to provide better care to patients at the point of need," he said.
For example, it may be better to produce small batches of vaccines deep inside developing countries, instead of trying to keep the vaccines refrigerated while transporting them hundreds or thousands of miles.
Similarly, a small bioreactor could produce drugs for a patient with a rare tumor — personalized drug production to go along with personalized treatment.
The biopharmaceutical industry is ready for dramatic innovations, said Barry Buckland, former head of bioprocessing at Merck and now a drug industry consultant.
"There's been significant breakthroughs on many technology fronts," said Buckland, who collaborates with Love on another project and is enthusiastic about the tiny bioreactor. In the worst case, if the objective as written wasn't met, there would still be significant advances made that would benefit the whole field."
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