TOX and CTM Manufacturing at Eurofins BPT
In the drug development process, drugs undergo a rigorous journey from target identification to new chemical entity identification, involving the screening of tens of thousands to potentially hundreds of thousands of compounds. Preclinical pharmacology and toxicology play crucial roles in translating laboratory findings to clinical applications. Toxicology studies, conducted in accordance with Good Laboratory Practices , assess the impact of pharmaceuticals on biological tissues and living animals, mimicking anticipated human exposure routes. Eurofins BPT, based in Jacksonville, FL, supports both toxicology and clinical trial material (CTM) requirements by preparing scaled-down batches using formulations and processes akin to finished products. In San Diego, CA, Eurofins BPT employs a state-of-the-art fill-finish facility with a gloveless, robotic isolator for sterile CTM filling, ensuring optimal sterility through real-time data monitoring and minimizing contamination risks.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
3D Screen Printing: Enabling A New Generation of Complex Formulations
April 14th 20253D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.
ROSS Ribbon Blenders - Video in Action
March 26th 2025ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.
