CBC, Scarab Genomics form agreement to increase manufacturing yield of Solinex rhu-pGSN

Apr 30 2010

Critical Biologics Corporation (CBC) and Scarab Genomics announced today a strategic agreement to substantially increase the manufacturing yield of CBC's lead therapeutic protein candidate, Solinex™, an intravenous formulation of recombinant human plasma gelsolin (rhu-pGSN). Solinex™ is in Phase 2 development to determine whether plasma gelsolin replacement therapy can prevent critically ill patients from developing many of the life-threatening complications that appear to be strongly associated with hypogelsolinemia, including acute respiratory distress syndrome (ARDS), severe sepsis syndrome, multiple organ system failure (MOSF) and death.

“Scarab's CLEAN GENOME® E. coli appears to be the host of choice for optimizing cloning performance and maximizing production efficiency of proteins like plasma gelsolin”

"Scarab's CLEAN GENOME® E. coli appears to be the host of choice for optimizing cloning performance and maximizing production efficiency of proteins like plasma gelsolin," said CBC's Chief Executive Officer, Mr. Ashleigh Palmer. "We have been deeply impressed by Scarab's 5-fold increase in production yield to over 13 g/L at 5L fed batch scale," he added. Under the terms of the agreement, CBC will obtain a license to Scarab's patented Clean Genome® E. coli for the manufacture of rhu-pGSN, and Scarab will use rhu-pGSN as a test protein for demonstrating the technology's benefits to other prospective clients. Financial terms were not disclosed.

Scarab Genomics has bioengineered its Clean Genome® E. coli host by removing over 15% of the bacteria's genome. Elimination of all prophage remnants eliminates cell lysis problems during production. Removal of recombinogenic mobile IS elements eliminates problems of genome and plasmid stability. Optimal performance with minimal salts medium and removal of hundreds of unnecessary proteins lowers costs by increasing metabolic efficiency and focuses cellular energy on the target. Increased percentage yield also drives down downstream processing costs. Genes for toxins, virulence factors, flagella and fimbrae have also been removed to improve product purity and safety. "Simply stated, genome reduction optimizes E. coli as a biological factory in all the important production related dimensions," explained Dr. Fred Blattner, Scarab's Chief Executive Officer.