Explore Our Charleston, SC Facility
Our products and services are designed to streamline workflows and supply chains, ensure the integrity of test data, and allow you to release products with the confidence of total quality control
Laboratories and Facilities
- Extensive site security and monitoring systems
- 44,000 square foot (4,088 m2) GMP manufacturing facility with supporting laboratories
- Technical service laboratory
- Contract bacterial endotoxin testing services
- Contract Celsis® method validation, suitability, and development services
- 6,000 square foot (557 m2) facility dedicated to collection of crude lysate from the Atlantic horseshoe crab (L. polyphemus)
- Solar power generation in 2020 with the addition of a new General & Administrative building
- Founded as Endosafe® in 1987
- Acquired by Charles River in 1994
- Over 300 employees
Investing in advanced manufacturing is more than just increasing efficiency, it reflects our company's commitment to being at the forefront of technology in a rapidly evolving environment. Automation allows us to produce our products with the greatest precision, consistency, and safety."
Niall Power, Senior Site Director, Charleston
Compliance, Certifications, Accreditations, and Professional Affiliations
Charles River’s Charleston, SC facility operates in compliance with the following regulatory agencies or accredited
organizations:
- Food and Drug Administration (FDA) License Number #1197
- South Carolina Department of Natural Resources (SCDNR)
- South Carolina Board of Pharmacy (Non-Dispensing Drug Outlet)
Quality and Process Initiatives
- Current good manufacturing practices (cGMP)
- Quality System based on 21 CFR Part 820, compliance through Biological License Agreement on file with the FDA
- Routine FDA surveillance (CBER and CDER)
- On-site IT support, customer and technical services, and operations engineering team
- Excellent history of regulatory compliance
Product and Service Offerings
| Product/Service | Description |
|---|---|
| Manufacturing of Endosafe® LAL products and accessories |
|
| Rapid Microbial Detection |
|
3Rs: Replace, Reduce, Refine
We embrace the commitment to advance responsible science through the 3Rs to help lead and collaborate on the progressive pursuit within the industry regarding animal welfare.
- Replacement: Endosafe® Trillium™ is a robust, recombinant cascade reagent that does not use horseshoe crab blood for the source materials, or any other animal derived products, further strengthening our commitment. Celsis® reagents are sourced through recombinant or sustainable sources
- Reduction: For over 20 years, our flagship Endosafe® LAL Cartridge Technology has allowed us to optimize our resources and refine our formulation while reducing our reliance on the horseshoe crab by eliminating 95% of the raw material via microfluidic technology.
- Refinement: Our R&D team continues to challenge and optimize our LAL formulation to introduce creative techniques and methods to utilize less raw material from the horseshoe crab.