SYN-004 , an oral beta lactamase enzyme ,which is a synthetic Biologic's proprietary drug helps in prevention of Clostridium difficile (C.difficile) infections.
The initial 750 liters cGMP(current Good Manufacturing practices) production run on FuJifilm's "pAVEway" platform yielded an unprecedented(Novel) 5.5 Kilograms with 95+% purity of SYN-004 API (Active pharmaceutical ingredient) drug,which will be used to support Synthetic Biolgic's phase1 and phase2 trial's and continued R&D studies .
SYN-004 is the first therapy designed to neutralise Intravenous antibiotics in Gut.SYN-004 is intended to maintain the balance of bacterial flora in Gastro Intestinal tract ,also know as "gut microbiome",which in turn will prevent devastating effect's of Clostridium difficile infection .
Clostridium difficile is a multi-drug resistant bacterium that is believed to infect 1.1 million US patients every year.
The initial 750 liters cGMP(current Good Manufacturing practices) production run on FuJifilm's "pAVEway" platform yielded an unprecedented(Novel) 5.5 Kilograms with 95+% purity of SYN-004 API (Active pharmaceutical ingredient) drug,which will be used to support Synthetic Biolgic's phase1 and phase2 trial's and continued R&D studies .
SYN-004 is the first therapy designed to neutralise Intravenous antibiotics in Gut.SYN-004 is intended to maintain the balance of bacterial flora in Gastro Intestinal tract ,also know as "gut microbiome",which in turn will prevent devastating effect's of Clostridium difficile infection .
Clostridium difficile is a multi-drug resistant bacterium that is believed to infect 1.1 million US patients every year.