We are dedicated to providing the highest quality analytical packages to support successful development of biopharmaceuticals from pre-clinical development to commercial launch.
Although every analytical technique provides specific information, thorough product knowledge is only achieved when orthogonal methods are carefully and strategically combined.
Eden Biodesign’s scientists have extensive knowledge of established and emerging analytical techniques. Therefore, we are ideally placed to evaluate methodologies and conduct analytical development for any given process or product.
Extensive in-house capabilities for advanced product analysis enable us to undertake comparability and characterisation studies for global regulatory submissions. This includes identification and complete characterisation of biosimilar key product quality attributes.
Our analytical GMP Quality Control group is experienced in the comprehensive array of microbiological and analytical compendial testing methods required to ensure product quality and safety. The QC team support in-process testing, bulk drug substance and drug product analysis, and formulation/stability studies for any class of product. We also have considerable experience in transferring analytical methods and have a structured process for assay qualification and validation.