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Appendix III: Scope of Service of CUHK Service Units
Blood Products
Generics
BA / BE
HKIB
DDC
Centre for Clinical Trial
CUCAMed
HKIB additional targeted area
Product
Registration
Vaccine
Commercial
Production
Fermentation products
of TCM origin
Design, engineering consultation, Validation Documentation,
Plant Integrity Testing
Recombinant Proteins
Process Scaleup, Process
Improvement,
Purification,
Process
Validation /
Evaluation
Construction of
Production Plant
Cell Banking
Cell Line
Characterization
Gene Cloning
Protein
Characterization
Phase III
Biopharmaceuticals
Characterization
& Assay
development
Regulatory &
Consultancy
Clinical Trial
Formulation,
stability, in vivo
ADME/T
Phase I & II
In-vitro
ADME/T
Monoclonal
Antibodies
Legend:
Clinical Trial
Production
Formulation
development,
stability test, in
vivo ADME/T
Chemical
Drugs
Biologics
Process
Development
TCM
Physical,
Chemical or
Biochemical
Characterization
Further Sub-class
Dosage
Formulation
Drug Discovery
Drug
Class
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