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 On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.
