Charles River Endosafe

Charles River Endosafe 1023 Wappoo Road Suite 43-B Charleston, SC 29407 Tel: (800) 762-7016 (843) 766-7575 Fax: (843) 766-7576 www.endosafe.com endo-comments@criver.com Founded:1987

Description

Endosafe was founded in 1987 by James F. Cooper, a pioneer in the field of Limulus Amoebocyte Lysate (LAL), with the goal of offering the most innovative products and the best technical support in the industry, The company's strength has been its close affiliation with its customers. This unique relationship allows Endosafe to respond to customer needs and react quickly to changing regulatory trends. This customer approach is apparent in the quality of both the products and the personnel at Endosafe.

Markets

Endosafe endotoxin detection products and services are used in the global pharmaceutical, biotechnology, medical device, clinical, and contract testing industries. Endosafe sells direct to customers in the United States, Canada, France, Germany, the United Kingdom, and Spain. Other European, Latin American, and Asian countries are supplied by Endosafe's network of distributors.

Services

Technical services provided by Endosafe include the following:

*Contract testing

* Methods development

* Product validation assistance

* Regulatory compliance consultation * Ont-site training and demos

* Training workshops and seminars

* Instrument qualification

* Technical response by phone, fax, and through the Internet

Products

The EndoScan-V Endotoxin measuring software program and BioTrend database trending software are new additions to Endosafe's high-quality line of endotoxin detection products. Both software programs are fully validated and compatible with most instruments in the market. Other Endosafe LAL products include the following:

* Two turbidimetric lysates, including KTA2, a revolutionary lysate unique to Endosafe which offers the best sensitivity and linearity in the industry

* A kinetic chromogenic lysate with extended stability, available in kits or in bulk

* An endpoint chromogenic assay that offers quick results over a limited standard curve range

* Single-test and multi-test gel clot lysate

* A full line of LAL accessory products along with certificates of quality.

Facilities

All of Charles River Endosafe's endotoxin detection products are manufactured in an FDA-licensed facility located in Charleston, SC. This facility has recently been expanded to 16,000 ft2 and is ISO9002 certified. The building includes two Class 100 clean rooms and houses all critical manufacturing operations. Those operations include receiving and inspection of raw materials, sterilization and depyrogenation of solutions and containers, aseptic filling, quality laboratory functions, and the warehousing of finished goods. Strict environmental monitoring and regular training in all areas ensure continued compliance with applicable regulations.