Endotoxin test-GettyImages-1338727745 Bacterial Endotoxin Testing, Part 1: Overview

All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.


Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.



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