With a vast array of biologic drugs failing to make it to the clinic despite hefty investments, researchers are seeking ways to identify promising candidates earlier in the pipeline to prevent wasted resources.
Stability assessment techniques are a useful tool that can be applied at each stage before a drug reaches the clinic, including expression and purification, candidate library development, formulation optimization and developability screening.
This infographic highlights how utilizing these measurements to evaluate essential attributes enables researchers to make informed decisions, ultimately improving the chances of successful drug development.
Download this infographic to explore:
- Key stability assessment technologies that can provide crucial insights into biologics’ stability and quality attributes
- How these technologies assess stability attributes to select promising candidates and optimize formulation
- How to save time and resources while increasing your biologics’ chance of success in the clinic
With the large number of biologic drugs that fail to reach the clinic despite high investment costs, researchers must find ways to choose more promising candidates earlier in the pipeline, so that investment isn’t wasted • Express and test expression levels • Sequence analysis • Measure and optimize yield • SEC or IEC clean-up Expression and purification • Phage display • AI-generated construct design • Random mutagenesis • Rational design Candidate library development • Buffer selection • Accelerated stability studies • Expression/purification optimization for scale-up • Thermal and colloidal stability improvement Formulation optimization • Assess select critical quality attributes • Measure affinity/avidity • Triage candidates with worst attributes • Optional: further improve best candidates with rational design Developability screening • PTM assessment • Non-specific binding determination • Self-association prediction Pre-clinical characterization Use parameters from nanoDSF, DLS, and backreflection to train AI Use DLS to confirm prep purity post-column Use nanoDSF, DLS, SLS, and backreflection to measure CQAs Use nanoDSF, DLS, SLS, and backreflection to screen optimal buffers Use DLS for accelerated stability studies Use DLS or SLS for self-interaction prediction Use nanoDSF to confirm thermal stability profile Target selection Investigational new drug approval (IND) Read more to see how stability measurement technologies are helpful during the various requirements in biologics development before a drug even reaches the clinic Biologics researchers turn to developability profiling to evaluate a wide variety of biophysical and physiochemical properties of their candidates, and with these extensive matrices of parameters decide which candidates are best for moving to scale-up and pre-clinical evaluation. There are a large number of developability attributes researchers evaluate, but some of the most common center around stability – asking if a biologic well-folded, active, and pure in its buffer, and whether it remain that way over time. Biophysical characterization measurements from nanoDSF, DLS, backreflection, and SLS are valuable for providing this information without using a lo