Lead and Clone Selection
Intelligent and targeted lead and clone selection is a critical foundation in the development of biologics and biosimilars, with a direct impact on timelines and overall project costs. At Biofidus, we support you with analytical, data-driven lead and clone selection studies so that you can focus your resources on candidates with the highest likelihood of technical and clinical success.
Why Lead and Clone Selection Matters
During early development, it is essential to identify lead molecules with the most desirable properties in terms of high efficacy, low toxicity and suitable pharmacokinetics (PK). Equally important, for economically optimized production, is the selection of clones that consistently deliver high product yields and quality in subsequent cell line and process development.
By investing in thorough, empirically based analytical lead and clone selection, you can:
- Shorten development time
- Reduce costly late-stage failures
- Build a strong CMC and quality foundation for your biologic or biosimilar
Analytical Lead Selection for Biologics and Biosimilars
Our lead and clone selection studies focus on the head-to-head analytical comparison of candidate molecules.
This allows you to prioritize lead and clone candidates that combine favourable efficacy, safety and developability profiles, fully aligned with your biologics or biosimilars development strategy.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
