by getting increasing order volume from academics who otherwise wouldn’t buy at higher prices, while richer pharmaceutical customers are running ever-more ambitious experiments. Cheap genes on demand now make it possible for researchers to order up 1,000 different variations of genes for an antibody drug candidate, so a pharma company can filter out the candidates with the very best properties in a far more efficient manner than the process they used a few years ago, Mulligan says.
And Blue Heron has been able to remain stable by keeping its internal costs down. The payroll has been limited to about 35 people for the past six to eight years, while Blue Heron has invested more and more in automated equipment. That has enabled the company to increase its output of manufactured genes 10-fold. “We have one of the highest revenue per headcount rates in the gene synthesis industry,” Mulligan says.
That’s no small thing in a globally competitive niche. Blue Heron’s rivals include Germany-based GeneArt, Coralville, IA-based Integrated DNA Technologies, Menlo Park, CA-based DNA 2.0, and Piscataway, NJ-based GenScript. Hard data on the size of the market these companies are pursuing is elusive, but Mulligan says biomedical researchers alone spend at least $1 billion worldwide each year on acquiring and modifying DNA, and there are growing uses for advanced materials and biofuels.
Venter has been using the Blue Heron service for at least five years as part of his synthetic biology quest, Mulligan says. Steady progress like Venter’s has paid off with repeat orders, Mulligan says.
“It helps to have built up a history, the technical capability to carry out the work, and many customers who have worked for us for years and trust us,” Mulligan says. “Those are assets you can’t create overnight.”
While trust takes a long time to build, it can be lost in a heartbeat. So while ethicists are debating the implications of Venter’s new synthetic bacterial cell, Mulligan was pretty open about a totally different ethical question that’s vitally important to his company.
It turns out that the five custom-gene manufacturing companies, while fierce competitors, have voluntarily joined hands to regulate themselves through the “International Gene Synthesis Consortium.” These companies have mutually agreed on standards designed to make sure that bioterrorists can’t order up a recipe for a plague-like pathogen, or dupe each of the companies into handing over key ingredients that could be assembled separately in a lab. Blue Heron has been working with federal officials, including some from the FBI, to make sure potentially dangerous genes don’t get into the wrong hands, Mulligan says. Blue Heron has a screening process to make sure that a researcher has a legit interest in learning something about a certain pathogen in order to develop, say, a plague vaccine.
While I’m normally pretty skeptical of the effectiveness of self-regulation, the gene synthesis consortium strikes me as a possible exception. After all, if terrorist ever got hold of a dangerous bioterror weapon that they were able to order over the Internet from one of the contract firms, that would kill the entire industry overnight.
“To get five fierce competitors to agree to work together on screening standards, in an international group, would be very hard to do with conventional regulation where no one company has jurisdiction over everybody,” Mulligan says. “The regulators are enthusiastic, and we are too. It’s definitely in our enlightened self-interest.”
