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Conducting Non-clinical Studies with Protein Biologics: Considerations in Test Article Characterisation and Method Development for Dose Formulation Analysis

With the increase in the number of protein biologics in development, including monoclonal antibodies, the proportion of GLP studies conducted for protein test articles has correspondingly increased.  Therefore, current GLP practices may need to be adjusted to accommodate the physiochemical characteristics of protein test articles. In terms of method development for non-clinical dose formulation analysis, analytical techniques specific to protein biologics will need to be used. Karina Kwok at MPI Research describes the current best practices applied in her organisation for test article characterisation and analytical method development of protein biologics for non-clinical dose formulations.
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