Scarab Genomics LLC is pleased to report the allowance of US Patent 10,604,736, “Materials and methods for extended continuous flow fermentation of reduced genome bacteria”.  The patented technology, branded “C-Flow”, is poised to revolutionize biopharmaceuticals production, delivering increased efficiency, reliability, consistency and safety, while facilitating rapid process development, thereby reducing time to market.

Many biopharmaceuticals are manufactured in bacteria, using “batch” processing, in which engineered cells cultured in very high volume vessels produce a therapeutic or diagnostic agent (protein, DNA, mRNA, etc.)  Such cultures grow for just a day or two, after which vast volumes of material need to be harvested and purified in one batch.  The US Food and Drug Administration (FDA) has long since advocated continuous rather than batch production of pharmaceuticals.  As the FDA’s S. Lee noted, “This method saves time, reduces the likelihood for human error, and can respond more nimbly to market changes. To account for higher demand, continuous manufacturing can run for a longer period of time, which may reduce the likelihood of drug shortages”.  Scarab’s C-Flow™ technology for the first time facilitates continuous production of large quantities of proteins and nucleic acids at constant levels in smaller volume vessels, saving dramatically on equipment and infrastructure costs.

Key to C-Flow™ is the company’s Clean Genome® E. coli set of engineered bacteria.  E. coli strains normally used for biopharmaceuticals production cannot sustain high levels of production indefinitely.  Moreover, these strains contain dozens of genetic elements that can compromise biopharmaceuticals production, including viruses and some elements (“Insertion Sequences”) that may be able to integrate into the human genome.  All of these have been removed from Clean Genome® E. coli, along with many nonessential genes, creating bacteria that produce more efficiently, more reliably, more safely and, critically, indefinitely.  US patent 10,604,736 discloses how the continuous fermentation is achieved, using remarkably simple equipment and inexpensive culture media, characteristics that improve purification steps, resulting in higher quality products.

Nucleic acid vaccines are coming into their own following recent success with rapid development of effective vaccines against Covid-19. However, most E. coli strains used for nucleic acid production contain multiple IS elements that can transpose into the desired production sequence, compromising the product, or into the regulatory elements, compromising production. Use of Scarab Genomics’ Clean Genome^® E. coli completely eliminates these problems, delivering more reliable production and safer products.