Associate Director Teva Pharmaceuticals West Chester
The impact of utilizing various amino acids as excipients, stabilizers, and viscosity reducers will be explored and discussed in conjunction with the challenges encountered during drug product development. Furthermore, this presentation aims to elucidate a potential mechanism involving amino acids in protecting protein molecules against aggregation in liquid formulations.
By employing different amino acids as excipients, we can gain valuable insights into their specific roles in stabilizing proteins and modifying viscosity. However, it is crucial to acknowledge that formulating with different amino acids, particularly at varying concentrations, can present certain challenges. By highlighting the potential benefits of using specific amino acids at optimized concentrations in preventing protein aggregation in liquid formulations, this study aims to provide insights into the selection of amino acids as excipients in formulation development.
Learning Objectives:
To review and understand the impact of utilizing various amino acids as excipients, stabilizers, and viscosity reducers.
To review the challenges and risks of using different amino acids as excipients during biologics drug product development.
Provide insight and guidance on selecting different amino acids in formulation development.
Discuss a potential mechanism and molecular insights into using amino acids to stabilize proteins
Review potential issues related to employing amino acids in drug product development, including their potential detrimental effects on protein stability and potential challenges in analytical tests.