Pyrogen Test

Our experts can design and develop an appropriate drug testing program for your biologics and provide available and customized test options to fit your specific needs. We support the testing of biological assays for all process stages, including sterility, microbial limits, antimicrobial effectiveness, pyrogen and bacterial endotoxin, etc. Pyrogen testing is a critical step in drug analysis and can determine whether or not your product is approved for marketing. CD Formulation is constantly updating our services and offerings as a provider of pharmaceutical formulation products and services. For pyrogen testing, we offer a variety of assays to meet your product's pyrogen needs.

Background

A pyrogen is a substance that produces heat when present as a contaminant in a drug or medical device. Most pyrogens are biological substances of bacterial, fungal and viral origin. Pyrogens can be divided into two categories: endotoxins and non-endotoxin pyrogens. Endotoxins are substances found in Gram-negative bacteria. Non-endotoxin pyrogens are other microbial substances, and sources include Gram-positive bacteria and viruses as well as yeasts and fungi. Sources of non-bacterial pyrogens include rubber particles, plastic particles, and metal complexes in elastomers. Injectable drugs and medical device products for implantation or other systemic exposure should comply with thermogenic restriction specifications prior to marketing.

Pyrogen Test Methods

Rabbit method

An infusion of the product or material is injected into a vein at the ear margin of a rabbit, and the animal's body temperature is measured several times over a specified period of time to observe changes in body temperature to evaluate the potential for the test product to induce a febrile response in the body. This method can visually reflect the warming process caused by pyrogen and can be used to examine a variety of pyrogenic substances.

Bacterial endotoxin assay

Bacterial endotoxin is a complex of lipopolysaccharide and trace protein on the cell wall of Gram-negative bacteria, which is a substance with endotoxin biological activity released only after bacterial death or disintegration. The method is based on whether the horseshoe crab reagent produces agglutination reaction with bacterial endotoxin to determine whether the limit of bacterial endotoxin in the test article meets the requirements. The method is simple and easy to operate, with low testing cost, rapid and reliable results, as well as high sensitivity for checking the specificity of endotoxin.

Pyrogen Test Services

CD Formulation performs pyrogen testing with speed and accuracy, providing rapid sample turnaround and technical expertise. Drug products for parenteral administration must be free of pyrogenic contamination, as these substances can induce life-threatening systemic inflammation in the recipient's body.

Pyrogen testing is divided into the following components.

• Endotoxin testing derived from Gram-negative bacteria
• Non-endotoxin pyrogen testing for Gram-positive bacteria, viruses or fungi

In addition to the above, we can also provide other services related to drug pyrogen testing, so feel free to contact us if you need a testing service that is not on the list. Our scientific staff can work with you to develop additional methods to meet the testing objectives.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.