The contract service organization (CSO) Aldevron was established in 1998 to offer plasmid DNA production services for the biomanufacturing of vaccines. The company’s two founders, John Ballantyne, Ph.D., now CSO and Michael Chambers, president and CEO, met as students at North Dakota State University (NDSU) in Fargo.
As an undergraduate, Chambers worked on an independent research project about DNA vaccines, which “had recently emerged as a very exciting new technology,” he says. Dr. Ballantyne was a graduate student in pharmaceutical sciences.
DNA vaccines consist of a small, circular piece of bacterial DNA or plasmid, genetically engineered to produce specific antigens of a pathogen. When the company started, DNA vaccine researchers used slow processes and harsh chemicals like cesium chloride to purify plasmid DNA. “We saw an opportunity to manufacture large amounts of DNA on a contract basis,” says Chambers, using a downstream purification process developed at NDSU.
Another problem with early DNA vaccines was that they worked well in mice, but often failed in larger animal and human studies. Aldevron solved the problem by licensing and developing DNA technologies, such as electroporation, and offering them to clients through the company’s GIA™ (Genetic Immunization and Antibody) service. “GIA rescued some DNA vaccines and increased the response to them 100-fold,” says Chambers.
Surprisingly, GIA also proved an effective way to make antibodies. Traditionally, animals are immunized with recombinant proteins or peptides to generate antibodies to a specific antigen. The combination of electroporation and DNA immunization, however, makes it possible to develop antibodies directly to a DNA sequence.
Nucleic acid production remains the flagship service at the Fargo facility, and more than 40,000 projects have been completed for clients working in research, preclinical, clinical, and commercial areas.
Aldevron is headquartered in Fargo and has subsidiaries in Madison, Wisconsin, and Freiburg, Germany. According to Chambers, the acquisition of Genovac in Freiburg in 2004 made it possible to produce high-affinity monoclonal and polyclonal antibodies, including antibodies to complex G-coupled protein receptors, directly from antigen-specific DNA sequences. He explains that the method does not require protein or peptide intermediates. “Our system goes directly from a DNA sequence to a plasmid that can immunize animals and create high-affinity antibodies to difficult antigens. This is Genovac’s expertise,” says Chambers.
The company opened its Madison facility in 2009 to expand its recombinant protein services using mammalian- and insect-cell manufacturing methods. The Aldevron team in Madison has strong expertise in protein purification and assay development as well.
“We now have three contract service platforms at our three sites,” says Tom Foti, vp and GM of Aldevron-Madison. He adds that this gives Aldevron an advantage over competing CSOs that focus only on DNA, protein, or antibody manufacturing. “As an integrated company, we can reduce the vendor base for our clients with the range of services and products we offer,” says Foti, who points out that many clients prefer to deal with one vendor instead of several.