Jennifer Meade, Aldevron’s new president, has been elevated from general manager, nucleic acids, where she led strategic initiatives that included expanding the company’s commercial footprint, and championing process improvements designed to better serve its clients and the overall market.
Meade joined Aldevron last year from Hologic, going from a global provider of diagnostics and medical imaging solutions with more than 5,500 employees working in more than 15 countries, to a CDMO with just under 1,000 employees at four sites, all in the U.S. Midwest.
Headquartered in Fargo, ND, Aldevron specializes in contract manufacturing of plasmid DNA, mRNA, proteins, and other key components used in vaccines, gene and cell therapies, immunotherapies, and molecular diagnostics.
“Number one, I think the space that Aldevron plays in is fascinating,” Meade told GEN Edge. “Two, there is so much potential to transform human health. For me, it’s incredibly important to do work that is meaningful, and that is leaving the world in a better place. And three, I think the spot that Aldevron is in as an organization with such growth potential ahead, with all this incredible talent and expertise to harness and really help this organization scale to that next level, it felt like a really attractive opportunity for me as a leader to come in and make an impact.”
Does making an impact include someday expanding Aldevron into an all-purpose CDMO?
“I certainly think that there are going to be opportunities for us to expand our capabilities and expand our business and move into other areas to better serve clients. ‘All-purpose’ to me feels a little generic size,” Meade said. “I think we need to stay true to our core. We need to appreciate and always live by our core capabilities and the science and innovation that has made us who we are, and make sure we’re leveraging that in a really thoughtful, methodical way if we choose to move into some new spaces. I don’t see us becoming a jack-of-all-trades by any stretch.”
Listening and anticipating
Before making any decisions to expand services, Meade continued, “we’re going to continue to listen to our clients. We’re going to anticipate. We’re going to respond to trends in the industry and think about the challenges our clients face and how we can best serve those.”
“In a growing market, our ability to serve them is dependent on making sure we have capacity, and we’ve got access to great talent,” she added. “We will be strategically looking to grow our space, our footprint to make sure that we can continue to serve.”
Aldevron is a stand-alone operating company and is brand within Danaher’s Life Sciences segment, along with Beckman Coulter, IDBS, Integrated DNA Technologies (IDT), Leica Microsystems, Molecular Devices, Phenomenex, and Sciex.
Life Sciences is separate from Danaher’s “Biotechnology” segment, which was formed last year and includes the Pall life sciences business, which Danaher acquired for $13.8 billion in 2015, and life-sci tools/service provider Cytiva, re-launched in 2020 after Danaher spent $21.4 billion for the former BioPharma business of GE Healthcare Life Sciences.
Aldevron recently drew upon the SA25 aseptic filling workcell of Cytiva and the lipid nanoparticle (LNP) formulation expertise of Cytiva’s Precision NanoSystems (PNI)—a provider of technologies, solutions and services for LNP delivery of genomic medicines—when it expanded its mRNA production capabilities. The expansion enabled Aldevron to offer “end-to-end” mRNA cGMP manufacturing services stretching from master cell bank to drug product in-house.
“The value that we see and that we believe we can bring to market through this expansion further down the continuum is a significant reduction in the time and complexity that it takes for clients to go from sequence all the way to finish drug product,” Meade said. “With fewer tech transfers, with fewer vendors, there will be an overall compression of that timeline. It’ll make it a much more seamless experience for clients by not having to transfer multiple times.”
“Intrigued” by mRNA expansion
Last March, Jefferies equity analyst Brandon Couillard wrote that the mRNA expansion would also benefit Aldevron by diversifying its revenue stream beyond its current mainstay of plasmid DNA.
“While Aldevron has historically over-indexed to plasmids (~90% of mix), we’re intrigued by the expanded mRNA offering, which we think will benefit from leveraging Cytiva/Pall’s client relationships & opens an attractive adjacent growth vertical (>20% CAGR [compound annual growth rate]) to complement Aldevron’s ~$500M+ rev biz [revenue business] w/ above fleet-avg margins (mid-40s EBITDA),” Couillard wrote.
On a conference call with analysts soon after the Aldevron acquisition, Danaher president and CEO Rainer M. Blair projected: “We expect the business to generate $500 million of revenue in 2022, with more than 20% annual revenue growth.” However, Danaher does not publicly break out Aldevron’s financial results or discuss the capabilities of its contract manufacturing operations.
Couillard reported that Aldevron had more than 325,000 square feet of capacity across its sites, a 20% increase since the Danaher acquisition. Couillard’s research note was based on presentations by Aldevron and Andelyn Biosciences, a gene therapy CDMO in which Danaher has taken a minority stake.
Aldevron also partnered with a sister Danaher company when it joined IDT on September 18 to announce a new global distribution agreement intended to expand CRISPR solutions for cell and gene therapy customers. IDT agreed to stock and sell three additional Aldevron-manufactured research use only (RUO) and cGMP CRISPR nucleases designed to help customers rapidly transition their research from discovery to clinical phases.
And in August, Aldevron disclosed its growing interest in supporting CRISPR-based drug development by highlighting its ongoing collaboration with 2020 Nobel Laureate Jennifer Doudna, PhD, and researchers at the Innovative Genomics Institute (IGI) at the University of California, Berkeley. (Doudna is IGI’s founder and chairs its governance board.)
Doudna served as corresponding author for a paper published by IGI researchers in Molecular Therapy detailing the ability of cell-penetrant Cas9 ribonucleoproteins (RNPs) to edit the mouse striatum when introduced via convection-enhanced delivery. The transient Cas9 RNPs showed editing of neurons comparable to Cas9 delivered using AAV9, as well as reduced adaptive immune responses.
Aldevron supplied IGI researchers with custom CRISPR protein with ultra-low endotoxin, enabling direct delivery to the brain in mice. Researchers reason that the technology could potentially avoid limitations of viral vector-based delivery including cargo capacity, immunogenicity, and cost.
“We believe that will help advance research in a few different genetic diseases, including Huntington’s and ALS,” Meade said.
Also in August, Aldevron signed a licensing agreement with Genentech, a member of the Roche Group, allowing the biopharma giant to use Aldevron’s Nanoplasmid® vector technology to manufacture novel therapies. The nonviral technology allows precise gene edits and transgene integration in primary human T cells, using plasmid donor DNA template and Cas9-RNP—a process that Genentech researchers detailed in a paper published last year in the Journal of Experimental Medicine (JEM).
“The significantly smaller bacterial backbone helps gene editing efficacy,” Meade said. “It also has an enhanced safety profile because of the smaller backbone and the lack of the bacterial coding regions there. It’s a very exciting partnership for us, and we’re excited to see what they’re able to do and discover and what they are able to bring forward by using that.”
Continuous improvement
As part of Danaher, Aldevron says it benefits from the parent company’s ongoing company-wide Kaizen or continuous improvement effort based on lean manufacturing and anchored on a common culture and operating system, called the Danaher Business System, focused on people, plans, processes, and performance.
Meade succeeds Kevin Ballinger, who served as Aldevron’s chief executive for three years before leaving the company recently. Ballinger, who succeeded company co-founder Michael Chambers, oversaw Danaher’s acquisition of privately held Aldevron for approximately $9.6 billion, in a deal completed in August 2021.
Making an impact has been Aldevron’s goal since Chambers and John Ballantyne founded the company in 1998, a year after both graduated from North Dakota State University (NDSU)—Chambers with a BS in biotechnology, Ballantyne with a PhD in pharmaceutical sciences.
Aldevron has expanded to two Fargo campuses. One is the “Breakthrough Campus” that serves as its headquarters, home to one of the world’s largest cGMP plasmid DNA manufacturing facilities. The other is the “Advance Campus,” anchored by a 45,000-square-foot manufacturing building and including three facilities integrated to support R&D, process development, and manufacture of plasmid DNA and mRNA for early-stage research.
Aldevron also focuses on developing innovative and proprietary plasmid technologies for cell and gene therapies at its “Impact Campus” which opened last year within the University of Nebraska Technology Park in Lincoln, NE.
And in Madison, WI, Aldevron provides custom process development, manufacture, and testing of recombinant proteins and enzymes to support research, diagnostic and preclinical applications within its “Innovate Campus” within the University of Wisconsin’s Research and Technology Park.
“You understand that your job is to get stuff made so the next people in the chain can make the discoveries that make the drugs that save the lives,” Ballantyne told the NDSU Foundation last year. “You don’t set out for glory or anything like that, but it is absolutely a remarkable thing to look back on when you see something that showed up 14 years ago, 12 years ago, that’s a drug now, and you can go back to your database and look at the first time it arrived and you made it. There are not many people in the world who get to experience that.”
