- The roll out of the liquid pre-formulation assessment for monoclonal antibodies and new modalities showed a significant impact in determining the success rate of developing a stable liquid formulation for biological entities.
- With early assessment for monoclonal antibodies, this success rate was close to 90%, wherein we saw that the data provided by our preformulation team was crucial to lockdown the Clinical service formulation in development organization.
- However, the portfolio now changing more towards non-mAbs such as Fc silencing formats, bispecific mAbs, therapeutics proteins and newer modalities such as gene therapies and AAV’s, designing a stable liquid formulation is more challenging. Moreover, platform formulations alone cannot be assessed for such modalities in the preformulation phase due to the complexity of the molecule and the narrow space for liquid formulations. Hence, a co-development of the clinical service formulation between the research and development organizations could enable in an in- depth understanding of the degradation pathways and the possibility of a stable liquid formulation.
- When divided into different work packages that comprises of the use of forced degradation studies and high throughput biophysical predictive tools, we could potentially answer key developability questions in the space of formulations.
Liquid pre-formulation assessment for monoclonal antibodies and new modalities showed a significant impact in determining the success rate of developing a stable liquid formulation for biological entities. The portfolio now changing towards non-mAbs like Fc silencing formats, bispecific mAbs, therapeutics proteins and newer modalities such as gene therapies and AAV’s, designing stable liquid formulation is more challenging. Co-development of the clinical service formulation enables an in- depth understanding of the degradation pathways and the possibility of a stable liquid formulation. With the use of forced degradation studies and high throughput biophysical predictive tools, key developability questions can be addressed.
Shwetha Iyer, Principal Scientist, Novartis
