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
In silico sequence liability analysis
In silico immunogenicity analysis
Turnaround time: 1 week
Developability Package 2
Polyspecificity assessment
Integrity and stability assessment
Turnaround time: 2-3 weeks
Developability Package 3
Buffer exchange
Forced degradation
Integrity and stability assessment
Additional stress conditions
Key Highlights
Heavy and light chain variable region liability analysis
VH and VL analysis with identification of core residues with potential affinity to MHC class II
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
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.