TOX and CTM Manufacturing at Eurofins BPT

Rick Camp, President, Eurofins BioPharma Product Testing ENCO (Raleigh & Jacksonville); Joe Page, PhD, Business Unit Manager, Eurofins BioPharma Product Testing (San Diego)

Prior to becoming a commercial product, drugs must pass through a complex development, review and approval process to ensure patient safety and drug effectiveness. From the earliest steps of target identification to the identification of a new chemical entity (NCE), tens of thousands to potentially hundreds of thousands of compounds are screened prior to proceeding to preclinical phase. Preclinical pharmacology and toxicology are critical process steps in the drug development process and are critical to the translation of findings from the laboratory and the clinic.

Toxicology studies (TOX) examine the impacts of pharmaceuticals on biological tissues, then on living animal subjects. The studies are intended to match, as closely as possible, the route or mode of administration to the anticipated human exposure. From a regulatory perspective, TOX materials are prepared under guidance from Good Laboratory Practices (GLPs), as outlined in 21 CFR Part 58. Prepared supplies are tested and released using qualified methods with oversight by both Quality Assurance and a Principal Investigator. Similar systems are employed for clinical trial materials (CTMs), often with added design assurances for aseptic products. Once a product reaches clinical phases, Good Manufacturing Practices (GMPs), 21 CFR Part 210/211, are utilized, from starting material manufacture to the use of validated analytical methods.

Eurofins BPT supports both TOX and CTM requirements at our Jacksonville, FL, facility by preparing scaled down batches, utilizing the same formulations and processes as closely as possible to those that will be utilized for finished products. TOX and CTMs can be provided in a variety of container closure systems, from sealed polyethylene ampoules, dropper bottles, to sterile vial systems. The use of single-use technologies for in-process materials and preparation reduces the overhead and expense of cleaning validation.

Eurofins BPT fills sterile CTM in our state-of-the-art fill-finish facility in San Diego, CA. Our gloveless, robotic isolator (Cytiva/Vanrx Microcell) with vapor phase hydrogen peroxide decontamination provides the greatest assurance of sterility compared to any RABS, open isolator or cleanroom currently available. Onboard sensors provide real-time data on the temperature, humidity, and 0.5 and 5.0 micron particles. Viables are monitored throughout the filling process with a TSB collecting bottle. This gloveless, robotic isolator removes the operator from the critical zone, the greatest source of contamination. The efficient design of this system, minimizes line loss to extremely low levels, delivering optimum results to clients and safe products to patients.