In general, how has the role of the Quality Control lab changed over the last 20 years and how has this evolution affected the pharmaceutical industry?
Over the last 20 years, adoption of Quality by Design (QbD) principles has expanded, increasing the assurance of safe, effective drug supply to the consumer, and significantly improving manufacturing quality performance. The Quality Control (QC) lab has played a key role in this evolution, as data generated by the QC lab is fundamental to continuous quality improvements that are characteristic of QbD. As part of a positive feedback loop of process improvement, the QC lab has become more integral to a company’s overall manufacturing operations, with interaction between operations and quality control expanding, and increased influence of the QC lab on design and development of processes compared to the past.
Over this same time period what has been Charles River’s mission? How has the company helped the industry bring safe and effective pharmaceuticals to market over the last 20 years?
From our small beginnings as a one-man company supporting scientific research to our present-day worldwide support network, Charles River has been committed to advancing human health for over 70 years. Our “every step of the way” philosophy drives us to act as a steadfast partner to our clients, from drug discovery to manufacturing support testing. By thoughtfully building our portfolio, our growth has become a continuous strategic effort in anticipating tomorrow’s drug development needs.
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In recognizing the unique microbiological challenges presented in the manufacturing phase of the pharmaceutical life cycle, Charles River has, over the last 20 years, tailor-made a division to serve these needs. Charles River’s Microbial Solutions division offers a broad portfolio of quality control solutions, building strength and expertise through the addition of Endosafe® in 1996, Accugenix® in 2012, and Celsis® in 2015. The Endosafe® brand provides a full complement of products and services in support of Bacterial Endotoxin Testing (BET) programs, including the only rapid microbiological method for endotoxin testing. Environmental monitoring (EM) support is available with the Accugenix® brand’s industry-leading microbial identification services and platforms. And in keeping with Charles River’s dedication to modern technologies, especially rapid ones, the Celsis® brand brings Enhanced ATP
Bioluminescence-based rapid sterility and rapid bioburden testing to our clients. All these modern micro methodologies allow for improved product testing, process verification, and ultimately increased patient safety.
What products and services does Charles River currently offer to assist pharmaceutical QC labs to give them the accuracy and confidence required for testing products destined for patients?
Charles River Microbial Solutions offers a full portfolio of products and services that support testing not only the products that are destined for patients, but also testing of the samples that give a more complete picture of the health of the manufacturing process itself. While assessing quality through end product testing is important, it is equally important that manufacturers build quality into those products through process control measures, then monitor the efficacy of such measures through in-process testing.
Some examples of Charles River’s process-control testing include microbial identifications of environmental monitoring isolates, point-of-use endotoxin testing of water systems with the nexgen-PTS™ system, and rapid microbial detection technology like Celsis® that allows for bioburden testing of raw materials and in-process checkpoint samples.
With respect to Accugenix® services, Charles River focuses strictly on modern microbial identification methodologies (genetic sequencing and MALDI-TOF mass spectrometry with industry-relevant reference libraries). Our proprietary microbial libraries paired with advanced identification technologies provide species-level microbial identifications with higher accuracy, reportability rates, and data integrity compliance than older phenotypic technologies so that our clients can have the utmost confidence in results, as these are used to make decisions about product quality.
Further, because all test results are most valuable when they are used to reveal trends and actionable information, Charles River provides clients tools for data analysis to achieve, maintain, and demonstrate control over manufacturing and testing processes. Our Accugenix® Tracking and Trending tool and our Cortex™ software for endotoxin data analysis are excellent examples of platforms that allow a company to take multitudes of individual test results and evaluate these as a whole, uncovering the story of what is happening within a facility or a manufacturing process. Such data-driven narratives are critical to maintaining complete process understanding and control.
Looking ahead, are there any quality assurance/control products, or testing technologies being developed now that will help pharma companies bring innovative products to the market? How is Charles River meeting this challenge for its current and future clients?
Charles River brings innovative products to market with input and constant feedback from our clients and colleagues working in pharmaceutical microbiology. Without such feedback, it would be impossible to ensure that we are meeting the industry’s needs and innovating to overcome challenges presented by current technologies and testing paradigms. As we develop new technologies, however, we remain committed to design products and services that uphold accuracy, data integrity, and regulatory compliance, while also advancing our clients’ performance and their patients’ safety.