Dosing of certain biologics, namely some monoclonal antibody therapies, may require hundreds of milligrams of the active ingredient. It is often desired that the dose administration can be managed by the patients themselves, i.e. by providing the dose in small volumes that are amenable to subcutaneous injection. As a consequence, high concentration formulations need to be developed, which often present challenges with regard to viscosity, as well as potential changes in the behavior upon stability. This webinar provides insights regarding the challenges of high concentration formulation development and suggests approaches to address them.
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