Early prediction of potential implication on safety and efficacy is key to successfully launch a drug product on the market. Read on how GE Healthcare works closely with the biopharma industry to improve current workflows associated with discovery, development, and manufacturing quality control by providing various types of bioanalytical solutions support.
Validating host cell protein (HCP) ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE™ approach combines the best of existing methods.
Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how SPR has been applied for protein characterization of antibody effector function.
This booklet is a selection of scientific posters describing how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.
Size exclusion chromatography (SEC) is currently the most powerful chromatography technique for obtaining reliable information about the size of biomolecules under native conditions. The formation of pores of a SEC resin is dependent on complex combinations of many parameters. Read more about all the parameters that affect resolution.
Principles of immunogenicity using
Biacore™ T200 SPR system
The assessment of unwanted immunogenicity is a key parameter in the development process of biological protein drugs. Usually, ligand binding technologies such as ELISA are used for early immune responses, whereas SPR technology is utilized for the characterization of antibody isotypes, which may be important for the interpretation of the clinical consequences of unwanted immunogenicity.
View this webinar to learn when and how to use the SPR technology to obtain a deeper understanding of unwanted immunogenicity.