Small Molecule Analysis Services for Bioprocess & CMC Support
The qualitative and quantitative analysis of small molecules is essential for understanding and optimizing the production processes of biopharmaceuticals and other APIs, whether they are produced in eukaryotic or prokaryotic cells or synthesized chemically. Small molecule analytics helps to detect substrate limitations, medium components, process-related impurities and the accumulation of potentially cytotoxic by-products, and is therefore a key part of CMC development, process control and troubleshooting.
At Biofidus, we provide standardized chromatographic assays for a broad range of small molecules, including amino acids, organic acids, polyamines, surfactants, sugars, process-related impurities, metabolites and more. Drawing on experience from hundreds of projects with small and large pharma clients, we have built extensive know-how in characterizing diverse classes of small molecules, enabling us to deliver tailored analytical services that accelerate development and optimize upstream and downstream processes.
In line with your needs, we adapt and, where required, qualify (according to ICH guidelines) our small molecule methods, tailoring them to your process, matrix and specific analytical questions, from early media and feed optimization to late-stage process validation and routine monitoring.
Get in contact with us to find the optimal strategy for your request and to speak directly from scientist to scientist.
