The phenomenal growth of Grand River Aseptic Manufacturing (GRAM) over the past 10 years didn’t slow during COVID-19 — if anything, the company has thrived.
With the recent completion of its new $60 million, 61,500-square-foot fill-and-finish facility at 524 Butterworth St. SW just west of the Grand River, the parenteral contract development and manufacturing organization (CDMO) has officially tripled its footprint and capacity — on time and under budget — drawing attention to Michigan, where GRAM is the biggest CDMO of its particular specialty, as far as the company knows.
That’s according to Tom Ross, president and CEO, who spoke to the Business Journal just before the facility’s grand opening last month.
Ross said most of the companies that do what GRAM does are located on the East Coast, mid-Atlantic or West Coast, such as Boston, San Diego and the “research triangle” in North Carolina — but the “exploding” growth of the life sciences and pharmaceutical industries positioned GRAM to become a leader in the Midwest.
“Obviously, we’re biased toward our Midwestern base. We feel like the quality of the employees and the quality of the work ethic and the level of talent in the Midwest is exceptional, and we think of this as an advantage compared to some of the other places in which we compete,” Ross said.
The company was founded in 2010 to acquire the assets of a joint venture between the Van Andel Institute and Grand Valley State University. GRAM provides sterile parenteral development, manufacturing, testing and regulatory filing support for the life sciences and pharmaceutical industries.
Parenteral refers to medicinal solutions administered somewhere in the body other than the mouth or alimentary canal, including injections or infusions that are intravenous (into a vein), subcutaneous (under the skin) or intramuscular (into a muscle).
GRAM’s aseptic manufacturing capabilities include sterile liquid and lyophilized (freeze dried) vial filling and finishing; terminal sterilization of vials; controlled substances handling and production; labeling and packaging; and storage and distribution.
Its services have both clinical and commercial applications — the former in research trials and the latter after a drug has received FDA approval.
With the new facility, Ross said GRAM will be able to better meet the demand for commercial work.
“We were limited before. … To be able to (produce) the drugs that require a high level of sophistication and technical competency, we’re better prepared to do that with this new facility and the new equipment.”
The new facility features a Grade C cleanroom, two formulation suites and $15 million worth of high-speed equipment — including a SKAN isolator and an IMA lyophilizer auto-loader, as well as a high-speed Bausch+Ströbel filling line that will enable GRAM to produce commercial batches of all sizes on the first floor, with plenty of room to grow on the building’s second floor.
Ross said he is proud that his team was able to work with the design-build firm they hired for this project, St. Louis-based CRB, to be fast and responsive in what was needed throughout the building process, so that CRB could finish within the projected 20-month window.
“We said we were going to do it, and we actually did it on time and a little bit under budget,” Ross said.
He noted that such a short time frame for a complicated project in the pharmaceutical industry is unheard of and has caused competitors to take note and look at GRAM as an example of what can be done.
Ross said he believes GRAM’s growth story fits into a larger narrative in the region.
“The growth in the life sciences and health industries in West Michigan has been fantastic over the years. By GRAM building a new facility — it truly is a world-class, state-of-the-art facility that will put Grand Rapids on the map in terms of pharmaceutical manufacturing and development capabilities (and is) either the largest or one of the largest new facilities in the United States in the last couple years — certainly with the emphasis on and demand for in the U.S. for drug products, I think we’re in a tremendous position to expand rapidly in the future,” he said.
“And when we do that, that continues to add to all the other expertise the community has relative to the life sciences.”
Ross said while GRAM’s customer base is all over the U.S. and to a lesser degree in Europe, GRAM has been lucky to be able to pull its skilled talent mainly from in-state.
“We are fortunate in West Michigan to have a (life sciences) hub, predominantly in the downtown area, and we’ve been able to continue to leverage some of those skillsets. When we recruit, there are great people in Michigan that have the skills that we need, and these are very technical positions that require a good amount of education and training and development,” he said.
“All those skills we have continue to bode well for the future, given all the market trends, certainly in our world of the parenteral drug space. The market is exploding, and being able to meet that demand all here in West Michigan is very exciting.”
GRAM never shut down during COVID, and in fact, did quite a bit of hiring, Ross said. The company now has nearly 200 employees — 40 to 50 of which were hired as a result of this expansion — and is currently hiring. Job seekers can apply at grandriverasepticmfg.com/careers.
Ross told the Business Journal in a previous report that GRAM was on track from day one to triple or quadruple its capacity and revenue, and that still holds true.
“If we had more cleanrooms or more equipment, it would be even above that,” he said.
GRAM landed on the Inc. 5000 list of the nation’s fastest-growing private companies in 2017, 2018 and 2019, with three-year growth rates of 791%, 703% and 173%, respectively.
Revenue numbers from 2019 were not disclosed, but GRAM reported 2018 revenue of $27.4 million to Inc. for the 2019 list. Quadrupling that figure would mean over $109 million in revenue this year.
“We’re a private company and we’re typically pretty humble about what we’ve accomplished, but it cannot be overstated the impact that we have in our industry,” Ross said. “The fact that we’re probably one of the top 10 CDMOs in the country now, here in Grand Rapids, Michigan, is something we’re extremely proud of.”