MIT: Building a Better Manufacturing Process for Novartis for $65m
In a Boston Globe article posted today, pharmaceutical giant Novartis announced that it would be contributing $65 million to the Massachusetts Institute of Technology (MIT) over the next 10 years to create a new research program with a goal of improving the current drug manufacturing process with better technology in order to save both time and money. The project, called the Novartis-MIT Center for Continuous Manufacturing, made sense given Massachusetts’ increasing visibility as a hub for both drug development and manufacturing, and it highlights the growing symbiotic relationship that is developing between biotechs and academics there. You can see the full article here.
MIT expects that the contribution from Novartis will fund as many as 10 faculty members and several graduate students, postdoctoral fellows and staff scientists. It will stand as the school’s largest industrial research collaboration, and officials believe it will be the largest focused effort on modernizing drug manufacturing in the world. Yet, for Novartis, the money contributed to this effort may be inconsequential in comparison to the amount of money spent developing drugs (an average of $1.2 billion for biotechnology products, according to a recent Tufts Center for the Study of Drug Development, or CSDD), and could have a significant impact in the costs associated with the manufacturing process.
But the Globe reports that the leap from traditional to continuous manufacturing may prove to be a difficult challenge. Unlike an automobile assembly line, controlled chemical reactions during the process make it difficult to establish an environment free of factors that might sully the finished product, such as contamination by other substances, minor fluctuations in temperatures, or even exposure to a certain spectrum of light. Personally I’d even be curious as to how these researchers would address the problem of ingredient sensitivity to these types of variations in the process and how small the margin of error might be.
In the traditional process, several steps are followed to assemble a drug from its ingredients, each one involving a manual process to test the purity of the batch prior to moving on to the next step. Not to oversimplify, but I’m sure it’s much like making your own wine, where at each point in the process, the sugars, acidity, and other characteristics are tested to ensure fermentation is occurring normally. If it’s not, steps can be taken to correct it at the point it’s discovered such that the wine can be saved. However, I don’t think the entire process of making wine can be automated without sacrificing quality, and that is the same fear associated with automating the manufacturing process for drugs. Bernhardt Trout, an MIT associate professor of chemical engineering who is running the collaboration with Novartis, said succinctly in the Globe article:
“We need to develop a whole of new set of technologies that don’t exist,” [Bernhardt] said. “We’re the first ones to try to put together all the resources to make it happen.”
The center will start by focusing its efforts on drugs made from chemicals because the challenge of working with biologic drugs - those made from living organisms - might prove to be too difficult. However, the need to develop a standard manufacturing process for biologic drugs is prominent in their minds because of the heavy concentration of companies in Massachusetts that might benefit from the new manufacturing process, such as Genzyme.
Regulation by the Food and Drug Administration (FDA) could also be a mixed bag for a new manufacturing process. On the one hand, several new requirements may need to be adopted and studies conducted before a new manufacturing process can satisfactorily be approved as a safe one. However, in recent months the FDA has shown flexibility in working with companies to allow them to develop methods that retain a high level of safety while also improving their cost-effectiveness.
I think it’s exciting to see an institution of MIT’s caliber receive these kinds of funds to develop new solutions that will improve a process that is outdated and costly to maintain. It gives students the opportunity to work outside of the realm of the theoretical and to see the fruits of their labor to potentially translate into a highly efficient and effective business model for some company. It can serve as a powerful buoy to a career if it is a successful endeavor.
However, given the relatively low cost of initiating the project ($65m really isn’t a lot for a drug giant like Novartis) and the anticipated cost savings in manufacturing if they’re successful, I wonder if this would translate into a cost savings for their customers, or a better bottom line for Wall Street. Or could it potentially be a benefit to both? What do you think? Would you take the money and run, reinvest it in your company, or pass savings to your customers? Would you share the manufacturing process with competitors? I would especially be curious if the process would be shared with or sold to generic drug companies, already a thorn in the side of the likes of Novartis, Pfizer and Schering-Plough.
I look forward to your thoughts.
