In May of this year, the J. Craig Venter Institute (JCVI) announced it had created the first fully synthetic, self-replicating bacterial cell (Mycoplasma nycoides JCVI-syn1.0). While this proof-of-concept demonstration of an “artificial life form” might raise justifiable fears about the dangers of unregulated or nefarious synthetic biology efforts, in fact the bioindustry has for some time been forging ahead with globally and commercially meaningful applications.
This fall, JCVI along with Synthetic Genomics (SGI), which was co-founded by Craig Venter and Hamilton Smith, formed a new company named Synthetic Genomics Vaccines.
The vaccines company has signed a three-year collaboration with Novartis to create influenza seed (starter-culture) strains for large-scale manufacture of flu vaccines. The intention is to reduce vaccine production time by having a bank of synthetically produced seed viruses; this should accelerate production of flu vaccines for seasonal or pandemic applications instead of relying on WHO’s more time-lagging distribution of live reference viruses.
“The rate-limiting step in developing seasonal flu vaccines is the production of pure vaccine seeds specific to flu virus strains that change from year to year,” says Jim Flatt, Ph.D., CTO at SGI. “Synthetically developing vaccine seeds provides the opportunity to significantly reduce the time to develop and produce the seed stock, thereby getting vaccines to market sooner.”
Roll-Out to Commercialization
Dr. Flatt says that SGI, through its supported research at JCVI, has developed a “one-pot, isothermal method to assemble pieces of DNA rapidly and accurately.” SGI is applying the platform to develop cyanobacteria for production of products ranging from biofuels to food and feed ingredients. Scientists at JCVI and SGI are also developing what they describe as a pioneering methodology to transplant whole genomes into recipient cells.
SGI says its milestones to date follow its predicted trajectory of the commercialization of synthetic biology products.
“The first products will likely be synthetic genomic tool-based products that facilitate more rapid, cost-effective synthesis and assembly of DNA molecules for both research and commercial purposes. Soon thereafter, we expect to see seasonal flu vaccines, developed from commercialized vaccine seeds,” says Dr. Flatt.
“Subsequently, one can expect to see engineered microbial biocatalysts and processes designed around commercialized biocatalysts—first in food and feed markets and, later, in agriculture and biofuels. The specific time frames to commercialize products in each of these fields is partially dependent upon receiving regulatory approvals both for products and manufacturing processes, which are unique to each market.”