Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials. Endotoxins may also compromise patient treatments, posing potential risks to the health and safety of end users. Historically, endotoxin testing has been performed using animal-based Limulus Amoebocyte Lysate (LAL) reagents; however, recombinant reagents are readily available and quickly becoming recognized as accepted comparable methods.

We will examine how endotoxin testing using recombinant reagents can support sustainability initiatives and goals while maintaining regulatory compliance. Key topics include the benefits of using recombinant reagents and the validation procedure for them. We will review a case study to gain further insight into the use of recombinant endotoxin testing solutions.

Attendees can expect to:

• Develop an understanding of what the testing using recombinant reagents entails
• Evaluate whether the BET using recombinant reagents may be a good option for device and pharmaceutical endotoxin testing needs.
• Apply the knowledge gained regarding the BET using recombinant reagents to their specific products, materials, and processes.