At the recent International Single-Use trade show in Boston, I had the opportunity to peek into the future of biopharmaceutical manufacturing. Just one problem — for biopharmaceutical manufacturers who aren’t prepared, the future is now, and the future is single-use. Here’s why.
Flexibility in Manufacturing
It’s always important for companies to quickly react to rapidly changing market dynamics. This has never been truer for the biopharmaceutical industry, which is on the cusp of a manufacturing revolution. Henry Ford built a car for the masses, available in any color, as long as it was black. The race to find cures for rare diseases and the advent of personalized medicine necessitate a different manufacturing process than one built for healing the masses. Don’t sell all your stock in companies who use stainless steel in their manufacturing processes just yet. There will continue to be a need for these types of plants where and when appropriate. However, from the sessions I attended and the vendors with whom I had the opportunity to meet, it is very evident that single-use allows for much greater flexibility in manufacturing than its stainless steel counterpart.
William Ciambrone, SVP with Shire (NASDQ: SHPGY) explained to a packed room how his company began building a manufacturing facility prior to the existence of the desired technology – a commercial size, single-use bioreactor, similar to the smaller scale model with which they were already familiar In order to do this, the plant had to be created with large open spaces and minimal infrastructure. The idea was to build a plant where vendor technology could be wheeled in and the manufacturing process would begin. Working closely with its vendor, Xcellerex, a prototype was created and tested. Working with the prototype provided Shire with some key advantages not initially conceived. One, it provided Shire operators with months of training opportunities, so when the final unit was put in place, they were ready to hit the ground running. Two, it allowed the companies to collaboratively work together to remedy equipment and automation issues. For example, the prototype revealed insufficient mixing formulation. Had they not seen this in advance, a unit would have been built and delivered with this defect, resulting in lost production time. The end results are impressive. The plant was completed and operational in only three years at 2/3 the size of a traditional manufacturing facility, using 87% less water and 30% less energy.
Kent Murphy, Sr. director at Pfizer Global Biologics (NYSE: PFE), echoed Ciambrone, saying that if a company wants to be faster to market with lower costs, then flexible plants are required. He envisions the facility of tomorrow as having non-dedicated suites where product changeover can occur more quickly and more frequently. Eric Garr, technical development scientist for Novartis (NYSE: NVS) explained how going single-use saved $500,000 for his company. He described how the plant being “plug-n-play” allowed for a quicker change over and a nearly 2/3 reduction lead time. That’s all well and good, but doesn’t the pharmaceutical industry already have production over capacity? Why build more manufacturing plants.
Mark Bamforth, president and CEO of Gallus, explained to me the process he went through in creating his new company, a CMO based on single-use. During the process of attempting to secure funding, he had to agree with both VCs and consultants that said the pharmaceutical industry has overcapacity. But, as he explained, it is not the right kind. The transportation industry serves as a relevant example. When automobile manufacturers began mass production of cars, horse and buggy makers had over capacity. The current overcapacity in the pharmaceutical industry is not capable of meeting the needs of personalized medicine. Single-use is poised to fill the void. One question, though: Is it “green” enough for us to swallow?
Single-Use – Going Greener
The vendors I spoke with made it clear that one of the biggest challenges they face is convincing customers how a disposable item can be good for the environment. Martin Hillary, national sales manager with 3M (NYSE: MMM), sees this as a constant struggle. Operators who pilot their new technology want it because it is so easy to use. Management, on the other hand, struggles with the counterintuitive nature of how something which is disposable can be good for the environment. Mani Krishnan, director at EMD Millipore (NYSE: MIL), explained to me how his company recognizes this challenge. “One can see the numbers with regard to water and energy savings, but ultimately, when you look over and see a garbage can full of stuff being thrown away, it doesn’t sit well with your heart,” he explained. His company is developing a program to creatively and productively deal with single-use waste. He wouldn’t go into the details, but perhaps we may see something similar to how used tires are being used to create energy. Stay tuned.