FUJIFILM Wako Chemicals U.S.A. Corporation, a supplier of high purity chemicals and reagents, and Predictive Oncology Inc., a leader in AI-driven drug discovery and biologics, have entered into a collaboration and co-marketing agreement to reduce protein interference in bacterial endotoxin testing of biopharmaceutical products.
 
Per the terms of the agreement, Predictive Oncology will utilize its novel EndoPrep sample treatment technology, together with Fujifilm’s PYROSTAR bacterial endotoxin detection reagent, to detect residual endotoxins more accurately in biopharmaceuticals by eliminating protein interference from the drug product in the detection assay.
 
Endotoxins – also known as lipopolysaccharides (LPS) – are components of the outer cell membrane of gram-negative bacteria and are released when intact bacteria are disrupted. Sub-nanogram levels of endotoxins can trigger immune responses such as inflammation and fever in patients, even leading to systemic shock and death. Endotoxins are highly resistant to sterilization processes, and accurate detection and removal of endotoxins in biopharmaceuticals are required before entering animal trials or human clinical trials.
 
The Limulus Amebocyte Lysate (LAL) test is recognized by the U.S. Pharmacopeia (USP) for determining endotoxin levels in many biopharmaceuticals. Fujifilm’s PYROSTAR ES-F LAL reagent is designed for the specific determination of gram-negative bacterial endotoxins, while also remaining unreactive to (1,3)-ß-D-glucan. The PYROSTAR ES-F LAL reagent accurately detects residual endotoxins in the presence of interfering glucans and, when paired with Predictive Oncology’s EndoPrep, reduces interference of most biologic products with the detection assay. In a proof-of-concept study, the companies achieved reproducible and accurate measurements of endotoxin in the presence of specific interfering proteins in biologics. The study results indicate that 75% of tested biologics went from not falling in the 50-200% detection range of challenge endotoxin to falling in the 50-200% detection range required by the FDA.
 
“We have a very powerful opportunity through this collaboration with Predictive Oncology to make a significant impact on drug safety by enabling the more accurate detection of residual endotoxins associated with biologic drug products,” said Lisa Komski, general manager, LAL Sales and Export Department, FUJIFILM Wako Chemicals U.S.A. Corporation.
 
“There is no question that Fujifilm has one of the best detection systems for measuring endotoxin levels in biologic drug products,” said Dr. Larry DeLucas, senior vice president, of Biologics for Predictive Oncology. “We have developed an advanced sample treatment product that allows pharmaceutical companies to prevent drug product interference with endotoxins, a technique which allows for a more accurate measurement of endotoxins that would have been masked by binding to the drug product itself.”
 
By bringing together Fujifilm’s PYROSTAR endotoxin detection technology with Predictive Oncology’s EndoPrep treatment kit, the companies will together be able to offer unique endotoxin solutions for injectable pharmaceuticals and biological products.