Unique expertise in analytical development for biological products
“Proven expertise for tailor-made CDMO biotechnology solutions.”
Our analytical team has strong expertise in developing methods for the characterisation of various molecules, monoclonal antibodies or native or recombinant complex proteins, as well as fusion proteins.
A complete range of analytical services
Our experienced analytical team offers a wide range of methods to support process development and pharmaceutical release of products. Our analytical laboratories at this LFB site have state-of-the-art equipment to characterise your product.
Routine analytical development and quality control activities include:
♦ Raw material testing and environmental controls,
♦ Development and validation of analytical methods,
♦ In-process controls for USP DSP processes: “upstream” and “downstream”,
♦ Testing and certification of the “drug substance” (clinical and marketing phases),
♦ Stability studies of the “drug substance” and “drug product”.
Our specific panel of analytical tests for monoclonal antibodies and proteins:
Our analytical team is experienced in the transfer, development and validation of methods, to ensure successful cGMP (BPF, French Good Manufacturing Practice) manufacturing of your “drug substance” or “drug product”.
