FUJIFILM Wako Chemicals U.S.A. Corporation (Fujifilm) and Predictive Oncology Inc. announced that the companies 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 (EndoPrep), together with Fujifilm?s PYROSTAR?

bacterial endotoxin detection reagent (PYROSTAR), 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 3 of 4 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. According to a recent report by Future Market Insights Inc., the injectable drug market is estimated to be approximately USD 6.0 billion in 2024.

During the period from 2024 to 2034, the market is expected to progress, registering a compounded annual growth rate of 5.8%. By 2034, the injectable drug market is anticipated to reach a value of USD 10 billion. 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.