From biologics to small molecule drugs, medical devices and personal care products, our team can design testing programs that promote the optimum use of resources. Our scientists, technicians and support team can provide the insight, advice and tools clients need to manufacture and release safe products with speed and efficiency.
- Manufacturing and Production
- Biologics Testing
- Endotoxin Testing
- Microbial Detection
- Microbial ID & Strain Typing
From early preclinical formulation development through clinical and commercial manufacturing and release, we provide timely, tailored science and services to support cGMP large molecule manufacturing. Our team of scientists can ensure the quality, consistency and integrity of a client's cell and viral banks, promoting a smooth and successful outcome for their manufacturing campaigns.
Our manufacturing/production capabilities include:
The approval process for ensuring the identity, potency, purity, safety and effectiveness of a biopharmaceutical is complex, and its effective navigation is critical to the ultimate commercial success of a product. With more than 50 years of experience, the Charles River Biologics Testing group has the proven knowledge, expertise and capacity to address challenging projects for biotechnology and pharmaceutical companies worldwide. Our primary emphasis is on quality, which is enforced through continuous training and internal audit programs, ensuring that our practices are in compliance with global regulatory guidelines.
We support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Our facilities in the US, the UK, Ireland, France and Germany are part of a global scientific network, offering services that span the entire drug development process. This allows us to offer clients greater flexibility, experience and expertise to maximize resources and optimize results based on specific program needs.
Our comprehensive biologics testing services include:
- Cell line characterization
- Contamination testing
- Endotoxin, MAT and pyrogen testing
- Impurity/Residual testing
- In vivo biosafety
- In vivo and in vitro potency testing
- Lot release testing
- Polyclonal antisera production
- Product characterization
- Stability testing
- Vaccine challenge studies
- Vaccine, biosimilar and cell therapy support
- Viral clearance studies
Whether customers need small volume traditional testing or want to process high-throughput samples, our endotoxin testing solutions offer technologic advances, from superior limulus amebocyte lysate (LAL) reagents and cartridge technology to sophisticated equipment and expert contract services.
Our revolutionary FDA-licensed LAL cartridge technology is at the heart of all our rapid methods, producing accurate, complete results in as little as 15 minutes. Flexible and easy-to-use, our solutions allow clients to perform real-time endotoxin testing, glucan concentration determination and gram identification at the point of sample collection or in the central QC lab. We offer single and multiple cartridge systems for smaller volume testing, as well as a fully automated robotic system for high-throughput and decreased user variability.
Our Endosafe® rapid testing systems include:
Our team has developed and optimized a complete portfolio of quantitative and qualitative FDA-licensed LAL formulations that provide increased sensitivity, greater linearity and superior interference resistance. Our line of reagents includes:
Partnership with our Technical Services group further helps clients achieve control, consistency and precision in their own laboratories. Our experts can provide the guidance and support that streamlines testing, ensures compliance and improves efficiency through product release. Our contract technical services include:
- Product validation programs – one and three lots
- Endosafe® LAL proficiency testing program (PTP)
- Regulatory compliance consultation
- Methods development
- On-site training
- Reader/Software qualification
- Product release/Stability testing
- Sample preparation
- Routine endotoxin detection for non-release applications
- SOP and protocol writing
Our Celsis® rapid microbial detection systems guarantee the safety of products manufactured by the pharmaceutical, home and beauty, and dairy, beverage and food industries. With quality assurance results in just 18–24 hours, Celsis® systems eliminate days from production cycle times and greatly reduce the impact of contamination events. This optimizes the supply chain and improves overall profitability by reducing inventory, warehousing and working capital requirements.
In addition to proprietary reagent technologies to support rapid methods,we offer complete systems that are specifically suited to the needs of small, medium and enterprise operations, as well as dairy manufacturers.
Our rapid microbial detection solutions include:
Our Accugenix® microbial identification and strain typing services lead the industry, offering unparalleled accuracy with the broadest reference libraries of relevant bacteria, fungi and yeasts found during the manufacturing process. Our dedication to industrial microbiology has driven the development and adoption of the most progressive technologies to improve environmental monitoring programs, reduce costs and protect our clients’ brands.
Accugenix® outsourcing solutions and Axcess® in-house technologies maximize our clients’ environmental monitoring program efficiencies with robust accuracy, providing the critical data necessary to make confident decisions and keep manufacturing moving forward.
Our identification solutions include: