Appendix III: Scope of Service of CUHK Service Units

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