Endotoxin Testing

As vital component of pharmaceutical and medical device manufacturing, endotoxin testing ensures products are free from fever-inducing contaminants—primarily endotoxins from Gram-negative bacteria—that can cause severe or life-threatening reactions in patients. As a result, manufacturers can validate aseptic processes and monitor water systems more effectively, which in turn helps prevent costly recalls and adverse events. Regulatory agencies, such as the FDA and EMA, require rigorous endotoxin testing for all injectables, implantable devices and parenteral products to safeguard patient safety and ensure product quality. Ultimately, by integrating rigorous endotoxin testing throughout the production process, companies safeguard patient safety, achieve regulatory compliance, and maintain high product quality.

Comprehensive Endotoxin Testing Methods

Cambrex offers robust endotoxin testing (bacterial and kinetic) and validation services to meet the diverse needs of pharmaceutical and medical device manufacturers:

• Gel Clot Method (Bacterial) – A qualitative assay based on the clotting reaction of Limulus Amebocyte Lysate (LAL) in the presence of endotoxins. This method is widely recognized for its simplicity and reliability in detecting endotoxin contamination.
• Chromogenic Method (Kinetic) – A quantitative assay where endotoxins trigger a color change in the LAL reagent, measured spectrophotometrically. This method provides sensitive, rapid and precise quantification of endotoxin levels.
• Turbidimetric Method (Kinetic) – Another quantitative approach, this assay measures the increase in turbidity resulting from the endotoxin-induced LAL reaction. It offers high sensitivity and is ideal for routine, high-throughput testing.
• Inhibition/Enhancement Testing – To ensure the accuracy of results, Cambrex validates that the sample matrix does not interfere with the LAL reaction, confirming the reliability of the test outcomes.

We can also develop custom protocols, tailoring testing strategies and method validation to address your unique product or regulatory needs.

Accreditation & Regulatory Compliance

Our endotoxin testing laboratories are FDA-registered, GMP-compliant and ISO 17025-accredited for medical devices, reflecting our commitment to excellence and regulatory compliance. Our methods are validated to USP <85>, EP 2.6.14, JP 4.01 and client-specific requirements, as well as aligned with other international standards, ensuring your data is accepted by regulatory agencies worldwide.

Expertise and Client Support

Cambrex’s team of experienced analysts and microbiologists deliver high-quality endotoxin testing with quick and reliable turnaround times. Clients benefit from direct access to a dedicated account manager, who coordinates with our technical experts and operations teams to ensure proactive risk mitigation, project alignment with client goals, clear communication and prompt issue resolution.

We also offer courier services for sample pickup and delivery within a 150-mile radius of the Agawam, MA facility, ensuring sample integrity and convenience for clients.