• The combined solution of EndoPrep™ and PYROSTAR™ ES-F can increase detection accuracy with most interfering biologics, minimize interference of peptides and proteins, and ensure compatibility with LAL and recombinant factor C assays for most biologics.
• The integration of these products can improve the process of endotoxin detection, a critical step toward Phase-1 clinical trials.

Combining EndoPrep™ from Predictive Oncology with PYROSTAR™ ES-F from Fujifilm Wako creates a powerful opportunity to impact drug safety by enabling the more accurate detection of endotoxins associated with biologic drug products.  This collaboration of resources enables biopharmaceutical companies the ability to overcome endotoxin testing challenges by avoiding two common interfering factors – ß-D-glucan and protein interference.

Overcoming endotoxin challenges
The Limulus Amebocyte Lysate (LAL) assay is a critical part of bacterial endotoxin testing (BET).  The assay depends on a complex cascade of enzymes to produce a clotting signal in the presence of endotoxin.  Due to the complex enzymatic nature of the test, the USP<1085> standard requires a test for interfering factors when establishing a BET protocol. Fujifilm’s PYROSTAR™ ES-F (LAL assay) and Predictive Oncology’s EndoPrep™ (sample treatment) products combine to address two of the most common interfering factors – false positives from ß-D-glucan and protein binding in the enzyme cascade. Fujifilm and Predictive Oncology recently completed a validation study which showed reduced interference from three different biologics.  

Validated success
In dual independent validation testing, the use of EndoPrep™ with PYROSTAR™ demonstrated the ability to reduce protein interference with a variety of common proteins.  With Sushi3 (known to bind endotoxin), hemoglobin, and IgG, EndoPrep™ improved detection of endotoxin during the spike recovery test required by USP<1085>.  

Interference of a biologic product with an LAL assay is a well-known confounding factor which is addressed by the Test for Interfering Factors in the U.S. Pharmacopoeia (USP). Unfortunately, the first line solution – heating the sample – often does not eliminate interference with the complex LAL enzyme cascade.  Use of the EndoPrep™ kit can reduce these interactions because it is designed to prevent interference (inhibition or enhancement) due to proteins thereby enabling more accurate measurements with the PYROSTAR™ ES-F/Plate Assay. The procedure defined in our sample protocol provides a rapid challenge test to determine the ability of EndoPrep™ to prevent interference with the LAL assay. The results demonstrate that the EndoPrep™ kit can reduce interference (inhibition and enhancement) for a variety of protein products. This makes the EndoPrep™ kit a valuable tool when used with the FUJIFILM PYROSTAR™ ES-F/Plate assay to achieve compliance with USP standards.

Benefits
Addressing assay issues in the complex LAL enzyme pathway using the combined solution of EndoPrep™ with PYROSTAR™ ES-F will enable biopharmaceutical companies to experience:

• Increased detection accuracy with most interfering biologics
• Minimized interference of peptides and proteins with endotoxin detection
• A straightforward example protocol to help validate and adapt the PYROSTAR™ and EndoPrep™ products into your testing procedures
• Compatibility with LAL and recombinant factor C assays for most biologics

Integrated solution
With the integration of products from Predictive Oncology’s Endoprep™ and Fujifilm’s PYROSTAR™ ES-F, biopharmaceutical companies can improve their process for endotoxin detection, addressing a critical step toward Phase-1 clinical trials.

Companies interested in this new solution can visit www.Predictive-Oncology.com/Fujifilm or use the Request Information button below to connect with the company.