- Development of LIVI for large biotherapeutics for FiH
- Understanding the degradation mechanism of a given therapeutic by performing accelerated stability and forced degradation studies
- Screening and assessing excipients that enhance protein stability
- Cross functional understanding of stability indicating assays to successfully lock a CSF
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