Blue Heron Biotechnology Inc. founder and CEO John Mulligan had seen the drug discovery process firsthand as director of genomics at Darwin Molecular, combined with his earlier work in genetics, when the idea for a new company came to him.

"What I realized is that there was an opportunity for a company that could industrialize part of the drug discovery process and make things faster and more efficient," Mulligan told BioWorld Today, noting that he had a "great opportunity" to see in a small company the whole range of the drug discovery process.

In 1999, Mulligan, who also had experience in establishing and managing one of two Human Genome Centers at Stanford University, founded Blue Heron Biotechnology in Bothell, Wash. The young company's mission - and accomplishment - is gene synthesis.

Today, the company said that it sells synthetic genes, gene fragments and gene variants to more than 40 percent of the top pharmaceutical and biotechnology companies worldwide. Those who might be interested in Blue Heron's products also include agricultural companies, laboratories and academics.

"Anyone who is studying a gene could potentially order from us," said Molly Hoult, senior vice president of sales, marketing and business development. And Mulligan noted that it even has academics who are working on synthetic peptides, which are "entirely novel sequences designed to be new proteins."

Use of Blue Heron's products have included determination of gene expression in tobacco to scientists working on antibody-based vaccines. There also is a range of species that scientists are interested in, ranging from worms to fish to humans.

The company introduced its first product, GeneMaker, in 2001, and although started with venture capital (genomics pioneer Leroy Hood was one of its seed investors) from Integra Ventures, of Seattle, and Crabtree Ventures, of Chicago, Blue Heron has generated revenue since that product introduction.

Earlier this year, Blue Heron reported that it received a $2.4 million grant from the National Institute of General Medical Sciences. It will use that grant money to "build, test and refine an automated DNA synthesis system capable of unattended production of 20,000 base pairs per unit in 12 hours," the company said. Mulligan said the project will basically be an improvement to a portion of its existing gene synthesis process.

Hoult said that the first bottleneck in the drug discovery process is getting access to DNA molecules.

"You need to find a way where you would efficiently find access to potentially thousands of genes," Hoult said.

She noted that Blue Heron also "can make any kind of complex variant" across a region of DNA that would be unreasonable to approach through traditional methods of obtaining DNA molecules, such as mutagenesis.

"The flexibility of this technology to make variants" is something Hoult doesn't believe anyone else is doing in the marketplace.

As an example, Blue Heron can put in every possible codon change to allow the purchaser of those genes to determine its expression.

"All the way through the drug discovery process, there is a need to make changes in a gene to answer questions," Mulligan said.

Mulligan pointed out that the industrialized system "allows people to tackle big projects. However, some requests may be for just a few genes.

"It can tackle 100 or 1,000 gene projects," Mulligan said, noting that "what that enables is taking a genomics approach to a whole set of genes."

Because the gene synthesis process is highly automated, the company has 23 employees.

"There will be some growth in terms of research staff to generate new products," Hoult said.