Developability For Complex Biologics & Bioconjugates

Understanding the Developability Challenge

Bringing a biopharmaceutical from discovery to market is an immensely challenging and expensive endeavor. Along the way, many promising drug programs fail to reach their full potential due to developability challenges. These setbacks can not only affect timelines and budgets but can also mean the difference between success and failure in bringing life-saving therapies to patients.

At Abzena, we de-risk the drug development process by assessing developability as early as possible. Developability refers to the likelihood that a biologic or bioconjugate will become a manufacturable, safe, and efficacious drug and, when employed effectively, aims to improve the likelihood of a molecule successfully making it to regulatory approval.

Our Unique Approach to Developability

The more you understand about your molecule earlier in the process, the better

Developability is fundamentally about understanding your molecule. At Abzena we approach this by trying to answer two simple questions right from the outset:

1. Can we make it?
2. Does it work?

To answer these questions, we combine decades of design experience together with the application of stage-appropriate assays to identify a handful of candidates with desirable properties from hundreds (or more) of initial candidates. However, developability isn’t static, with selection criteria needing to be continually refined in order to de-risk a project and move closer to that ideal drug.

This continuous and comprehensive approach ensures potential problems are identified and mitigated early, enabling a smoother transition through the development pipeline.

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