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target selection & validation
?
Immunotherapy
hit discovery
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Immunotherapy Lead generation (biology & developability)
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Immunotherapy Lead Optimization
?
cmc
?
Master
cell bank
Working
cell bank
Formulation
?
Development
formulation
Product
formulation
Quality Assurance, Quality Control & Analytical process
?
Bioproduction
?
Active
Principle Ingredient
Drug substance
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Final product released
Clinical Trials
?
 
 
Regulatory filing
?
post-market surveilance
?
Preclinical biomarkers
?
Clinical biomarkers
?
Companion biomarkers
?
 
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