Topics to be covered:
1. The diverse modality of therapeutic biological products: protein, gene, and cell therapy products
2. Analytical procedure development (new ICH Q14 2024) and validation (new ICH Q2(R2) 2024)
3. Product Stability: developability, forced degradation, pre-formulation, and formulation development
4. Product strength methods: protein concentration, DNA concentration, and viable cell density
5. Product purity/impurities methods: capillary electrophoresis (CE-SDS NR/R, cIEF, icIEF) and HPLC (IEX, RP, SEC, HIC, HILIC)
6. Product potency methods: biological activity (binding ELISA, functional activity, and CBPA)
7. Product identity methods: peptide mapping, sequencing, icIEF, binding ELISA, FCM
8. Product safety: methods of process impurities and contaminants for product safety (HCP by ELISA and MS, residual DNA, leachable ligand, mycoplasma, bioburden, endotoxin, sterility, and RMM)
9. Aggregate and sub-visible particle analysis (AUC, SEC-MALS, DLS, LO, FIM, MFI) to address immunogenicity concern
10. Extended characterisation by mass spectroscopy (LC-MS), multi-attribute method (MAM), charge variant analysis (CVA), glycan profile (HILIC and site-specific), sialic acid, qPCR, biosensor (SPR, BLI), and HOS by biophysical characterisation (CD, FS, DSC, DSF, TEM)
Who should attend?
The curriculum provides a broad overview of biologics analytical and characterisation strategies. It is beneficial to individuals involved in biologics drug discovery, developability assessment, analytical development, formulation development, process development, DS/DP manufacturing, quality control, quality assurance, clinical supply, regulatory affairs, CMC project management, or related functional areas.