The Backbone of
Product Safety

Patients like Niva fight to improve their quality of life every day with help from the medical and pharmaceutical industries.

So, what’s at risk?

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Interactive Experience

This network diagram highlights Niva's journey and expands to reveal how the Charles River Microbial Solutions portfolio is contributing in every area within the quality control testing and manufacturing processes to bring safe, effective therapies to patients.

To learn more and explore connections, start by clicking on any node below

Making Patient Safety Personal

Developing and manufacturing lifesaving therapies is a life’s work. Your work. The work of thousands of scientists who believe in a cure, a solution, a better way. It's also the work of millions of patients who fight side by side with you in the battle for a better quality of life. Our mission is to support you, your scientists, and your patients in this battle. It’s not just about helping you meet regulatory requirements, we want to help you set a new standard for the way you conduct quality control. We’ll help you provide the rapid and reliable results necessary to validate your decision to release a safe product to your patients.

Bacterial Endotoxin Testing

The ability to detect all environmental Gram-negative bacterial endotoxins is an important element of safe pharmaceutical production, medical device manufacturing, radiological health, and dialysis water testing fields. Highly sensitive and exquisitely specific in vitro assays are necessary to ensure products are safe for release, and alternative, non-compendial assays can return false negatives –potentially subjecting patients to a fatal pyrogenic reaction. With over 70 million tests performed annually, the LAL assay delivers confidence with every test performed. As a cGMP, FDA approved and licensed therapy manufacturer, the organization you partner with for your solutions should be held to those same standards too.

Are you confident your current endotoxin methods are detecting everything?

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Microbial Identification

The safety of your manufacturing environment depends on a clear picture of your microbial identification data. Without confidence in your environmental monitoring (EM) data, you can never be completely sure that your products are free from unwanted microorganisms. Consistent and diligent EM practices are some of the best strategies to achieve operational improvements that eliminate risk to patient health. Accurate and timely microbial identification is crucial for tracking and trending EM data that guide critical decisions and protect you from releasing contaminated products.

How can you ensure product quality if you aren't in control of your manufacturing environment?

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Microbial Detection

Assays that require a visual read for final sterility confirmation are no longer acceptable. Traditional methods don’t help you release product faster, detect contamination sooner, or eliminate all doubt when answering the question “is it safe?” Rapid microbiological methods (RMMs) are effective at modernizing the laboratory by transforming subjective decisions into unambiguous results. In an industry that relies heavily on cutting-edge technology, should final sterility really be proven with a visual turbidity check? With over 15 million sterility tests performed every year, it only takes one bad call to jeopardize countless lives.

Is close enough good enough?

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Patient Stories

We are passionate about improving the quality of people’s lives, and we are proud to play a role in bringing life-saving treatments to the patients in these success stories. They reflect our dedication to the discovery and development of novel therapeutics. Our purpose is clear and our passion is strong: Together We Create Healthier Lives.

In 2018, Charles River supported 85% of drugs approved by the FDA. By supporting developers and manufacturers from discovery through product release, we play a crucial role in delivering therapeutics to the patients who need them most. Patient safety is what fuels us to remain committed to providing high quality, effective products and services to the biotech industry, ensuring your end product is safe. Because ultimately, the quality of life depends on the quality of your products.

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