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Biologics Development

Wolfe Laboratories provides the highest quality translational support for the development of biological therapeutics. Wolfe Laboratories’ approach towards the translational development of a biologic compound is rational and science-driven based on a mechanistic understanding of a compound’s physicochemical and biophysical behavior. This allows the critical path development program to be highly efficient. For any given compound, an analytical strategy is developed to rapidly assess relevant attributes. Given the route of administration and the purpose of the studies, formulation and process development can proceed. As the compound advances and the formulation is refined, this approach obviates the need for major bridging studies. Formulations are evaluated for their performance and behavior that can be expected upon administration, using the appropriate predictive tests. The drug product is manufactured and tested, and the stage-appropriate stability studies are performed. Throughout this process, Wolfe Laboratories identifies and characterizes the benefits and risks and this knowledge can be leveraged throughout a molecule’s development lifetime. These activities are outlined schematically in the following figure.

 

Wolfe Laboratories’ integrated capabilities for development of biologic therapeutics

 

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