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Cell Banks MCB / WCB Virus Seeds MVS / WVS Pre-clinical + Phase I – III + comm. Drug Substance Manufacturing Drug Product Manufacturing Regulatory Support Technical Transfer Stability Tests
Immunogenicity studies Adjuvant evaluation studies Dose ranging/finding studies Toxicology studies
Formulation feasibility Characterization and assay selection Formulation optimization Development stability studies Device compatibility studies In-use stability study Lyophilization
Immunological assays Biochemical assays Biophysical assays Cell-based assays Analytical chemical assays
Clarification Chromatography Tangential Flow Filtration Dead-end-filtration Final filtration (sterile 0.2μm) Lyophilization
Mammalian Microbial fermentation Adherent Suspension Up to 200L
Viral vaccine design Bacterial vaccine design Therapeutic vaccine design Antigen selection GMP readiness
Bacterial vaccines Viral vaccines Conjugate vaccines E.coli expressed protein vaccines
Infectious Diseases Oncology Immunology Auto-immune diseases Neurodegenerative CNS AntiMicrobial Resistance Respiratory Parasitic and fungal
DiscoveryDevelopmentPre-clinicalGMP ManufacturingPhase I/IILarge-scale manufacturingPhase III/IVRegistration and distribution
