Therapeutic Developability Analysis
Evaluating the developability of therapeutic drug candidates early can help circumvent potential issues in late-stage development. These evaluations include the drug candidate’s biophysical and chemical properties assessment. At Curia, in silico predictive tools and a series of fast & small-scale assessments are employed to serve as additional selection criteria for better and safe therapeutic leads.
Curia offers three developability assessment packages:
| Developability Package 1 | Developability Package 2 | Developability Package 3 |
|---|---|---|
| – In silico sequence liability analysis – In silico immunogenicity analysis – Turnaround time: 1 week | – Polyspecificity assessment – Integrity and stability assessment – Turnaround time: 2-3 weeks | – Buffer exchange – Forced degradation – Integrity and stability assessment – Additional stress conditions |
Key Highlights
In silico Analysis: Application of Bioinformatic Tools
- Heavy and light chain variable region liability analysis
- VH and VL analysis with identification of core residues with potential affinity to MHC class II
Rapid Integrity Assessments and Formulation Studies for Drug Candidates
- Polyspecificity and integrity assessment can be completed in 2-3 weeks
- Formulation studies can be completed in 5 – 6 weeks, including the standard 2 weeks of incubation for accelerated stress conditions
Robust Bioanalytical Assays and Formulation Studies with Minimal Materials Required
- The standard panel includes common formulations used for commercial antibodies
- Various bioanalytical assays and characterization tools are provided
- A small amount of materials are needed for the bioanalytical assays and formulation studies.
Developability Assessment Services
Curia’s dedicated facility in Hayward for upstream and downstream process development, research cell bank (RCB) generation, and GMP manufacturing of analyte specific reagents.