Phase I: Identifying Candidates
- Internal proteomics programs OR
- External R&D co-operations OR
- Licensing-in markers OR
- Use of markers in public domain
Phase II: Prototype Development
- Collect highly defined sample panels AND
- Antibody development and pre-validation of antibodies AND
- Prototype assays (clincial sensitivity and specificity) AND
- Assay validation including alpha-site testing
Phase III: Product Development
- Switch to monoclonal antibodies
- Automated assay formats
- Production
- Alpha-site testing
- Registration
Zolg and Langen, MCP 3:345, 2004