Charles River Microbial Solutions

Activities: Regulatory Analysis

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe

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We’ve purposely built our QC Microbial Solutions portfolio to bring you progressive products and services that deliver accurate, relevant, and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.

Our products

Endosafe® endotoxin testing system remains at the industry forefront through continual development of new technologies and innovative products to improve and accelerate the development process. With our FDA-licensed products for rapid, traditional, or animal-free bacterial endotoxin testing, along with sustainable animal-free recombinant reagents, our clients can make confident decisions about the safety of their products with the most sensitive and robust BET solutions available.  

Explore our solutions: Bacterial Endotoxin Testing | Charles River (criver.com)

Celsis®, our rapid microbial detection solution, allows you to test and safely release products in half the time of traditional methods for sterility, bioburden, and microbial limits. By providing results in less than 7 days for sterility and less than 2 days for bioburden and microbial limits, Celsis® detects contamination faster, minimising the impact of contamination events on your manufacturing process. Learn more: Rapid Sterility Testing Solutions for Sterile Pharmaceutical Products | Charles River

Accelerate Your Path to Rapid Sterility Testing with Celsis® Validation & Implementation Support

Charles River now offers a streamlined pathway to faster implementation of the Celsis® rapid microbial detection method using Celsis AMPiScreen® (Amplified ATP Bioluminescence) for rapid sterility testing. Our two validation support packages are designed to demonstrate method equivalency, reducing the time to validation by 3 to 6 months. This accelerated timeline allows you to transition from installation to routine use of your Celsis® rapid detection system more quickly, enabling you to realise the benefits of rapid sterility testing sooner.

Charles River’s Accugenix® microbial identification and strain typing services offer unparalleled accuracy in identifying microbes with the most relevant reference libraries of bacteria, filamentous fungi, and yeasts. Specialising in bacterial and fungal identification and strain typing of environmental isolates, we use the latest DNA sequence-based and MALDI-TOF technologies to provide accurate and reliable microbial identification services to more than 1,000 facilities worldwide. Our flexible solutions allow clients to outsource to our experts or use our services in-house.

Specialised services

With more than 70 sites around the globe, Charles River is strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving your product’s unique challenges. Our focus on timeliness and accuracy in every stage of development means you can count on reliable, reproducible results, every step of the way.

Accugenix® Support:

For over three decades, Accugenix® has delivered accurate microbial identifications from our validated library and provided a 99% on-time delivery rate. We are continuously expanding our global laboratory service to ensure that no matter where you are in the world, you have convenient access and benefit from the expertise, sample analysis process controls and convenient tools like tracking & trending. With eight microbial identification laboratories worldwide, our global footprint of technical support laboratories operates with a shared network of expertise and experience, dedicated to identifying your microbial isolates and increasing your laboratory efficiency and accuracy in resolving contamination risks. As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensure the integrity of your microbial data, reduce risk, build efficiency, and improve your bottom line while assisting in the journey to bring products to market. Many of our sites not only provide Accugenix Identification Services but also encompass, Celsis® Rapid Microbial Detection, Endosafe® LAL support, instrumentation services, and hands-on client training.

Tracking & trending environmental monitoring data

Highly regulated industries are required to establish comprehensive and reliable quality systems and environmental monitoring programs that measure the state of control of their manufacturing facility and ensure data integrity. The Charles River Customer Web Portal includes a Tracking and Trending solution for all environmental isolates identified with Accugenix®. Recent enhancements offer customisation features for data entry fields and reports while meeting requirements of 21 CFR Part 11 and GAMP5 standards.  

Learn more: Environmental Monitoring Software for Tracking and Trending

Related resources recommendation:

Accugenix

Celsis

Endosafe

Links-outs to Eureka Blogs

Origin Story: A Mold’s Perspective | Eureka blog (criver.com)
Incorporating Quality Control Technologies in the Lab | Eureka blog (criver.com)
The History of DNA Sequencing | Eureka blog (criver.com)
The Evolution of Endotoxin Testing Eureka blog (criver.com)
Implementing Rapid Sterility Test Systems: A Guide from the Experts | Eureka blog (criver.com)
For more updates, check out: Microbiology-related Blogs | Eureka (criver.com)

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