Microbial Control in Cell and Gene Therapy Manufacturing

Reducing bottlenecks means ensuring robust detection and remediation of potential contaminations throughout the ATMP production process as well as during final release testing. Given the manual manipulations involved in many ATMP manufacturing processes, both environmental monitoring and in-process controls to detect bioburden are critical.

Furthermore, detecting bacterial endotoxins and ensuring final product sterility for microbial control are required when releasing product safely to patients. Please see this flowchart poster on how our rapid QC solutions compare against traditional methods in terms of time savings and efficiency

Environmental monitoring is the best way to evaluate the state of microbial control at your manufacturing facility and ensure your product is not subject to unnecessary setbacks due to personnel, materials, and the manufacturing suite’s environment. Accurate microbial identifications are critical for understanding the common microbial flora in your production environment so deviations from the norm or objectionable organisms can be apparent through tracking and trending of EM data. A comprehensive EM program is one of the best tools for preventing final product contaminations and reliable microbial identifications are critical for resolving contamination investigations.

A platform that is both flexible and meets the microbial control needs of a variety of sample throughput and different lab sizes and configurations, yet is FDA-licensed, accurate, and provides real-time endotoxin testing, glucan concentration determination, and Gram identification is critical for the safe release and use of medical devices and products per ATMP regulation. Our Endosafe^® endotoxin testing equipment and cartridge technology is our response to your lab’s needs for safe release and rapid results: 

Endosafe^® LAL Cartridge Technology: Cartridges reduce your sample test time and human touch points, as well as help your lab achieve sustainability goals while sticking with a compendial kinetic chromogenic method.

Endosafe^® nexgen-PTS™: The Endosafe^® nexgen-PTS™ is a rapid, point-of-use handheld spectrophotometer that utilizes USP/BET-compliant disposable cartridges for precise, convenient, and real-time endotoxin testing, glucan concentration determination, and Gram identification.

Endosafe^® nexgen-MCS™: Our multi-cartridge benchtop system addresses the need for higher sample throughput, capable of concurrently testing up to five samples within 15 minutes, allowing you to release your products more quickly.

Endosafe^® Nexus™: Automation is the future of BET testing. The Endosafe^® Nexus automated endotoxin testing system eliminates high-volume testing variables and reduces hands-on involvement to help improve data integrity compliance in your endotoxin testing program.

While endotoxin detection is required for releasing products to patients, it is not commonly a rate-limiting step. It is a known issue that traditional growth-based sterility test methods cannot address the needs of cell and gene therapy manufacturers when ensuring patient safety of ATMPs and short shelf-life products in a timely manner. With the traditional sterility test requiring a 14-day incubation period, products are typically administered at risk ahead of test results. Utilizing a sample preparation method optimized for products containing cells and ATP bioluminescence, Celsis^® rapid contamination systems can be used to release cell and gene therapies in as little as three days. This microbial control technology is compatible with both membrane filtration and direct inoculations, preserves the compendial test preparation method, and has proven compatibility with 20+ commonly used cell lines. 

In an industry that has gone from niche to the forefront of medical science research and drug development, the establishment of more stringent ATMP regulations and requirements is only a matter of time. By partnering up with Charles River’s Microbial Solutions, you also gain over nearly 30 years of experience in quality microbial control testing in making sure that there are no impurity related deaths for your patients. 

Our Endosafe^® endotoxin testing systems and reagents are the industry standard and are used to test thousands of on-market therapies. With Celsis^® rapid microbial detection, you can detect contamination and release final ATMP and short shelf-life products in as little as 3 days using a risk-based approach, or between 4-7 days using the traditional sterility testing method. If contaminations are detected in your product or during routine environmental monitoring, Accugenix^® microbial identification and strain typing laboratories can be used to outsource this testing, off-loading the need to maintain identification equipment or skilled technicians in house, and return results in as soon as one day.

We are not just Microbial Solutions with rapid quality microbial control products and services, we are also Charles River Laboratories’ research models, discovery, safety assessment, laboratory sciences, scientific and regulatory advisory services, biologics testing solutions, and cell and gene therapy CDMO solutions. In other words – you are in good hands.