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.
Cooperating With Our Customers Across the US
May 13th 2025Highlighting the importance for our clients to prepurchase multi-year maintenance contracts, in order to avoid their machines breaking or stopping to work suddenly and unexpectedly, to minimize the risk of interrupted production and emergency maintenance costs.
Large-Scale LNP Process Conversions: The many hurdles of LNP scale-up and what to consider
May 12th 2025Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.
Adding SYLOID® Mesoporous Silica to Improve Run Time and Yield for Micronization Processes
May 9th 2025A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.
