Module 9 2021

Control Strategy

Therapeutic protein

Impurities Host cell DNA (qPCR) HCP (ELISA) Column leakage

Purity Degradation / aggregation Charge heterogeneity

Identity Sequence (N/C and AA peptide map) Charge (IEF, SEC) Glycosylation Circular Dichroism

Concentration UV Absorption

Potency Bioassay (ELISA)

(ELISA) Free-SH

Appearance, Sterility, mycoplasma, Endotoxin, pH, osmolality, adventitious viruses

ATMPs

Impurities Host cell DNA (qPCR)

Purity Aggregates RCR/RCV/RCA Transduction

Identity Sequence Southern Blot Phenotype

Potency/func tionlaity Biological activity Viability

Concentratio n Viral copies (RNA) VNC/mL

HCP (ELISA) BSA (ELISA)

Benzonase (ELISA) Plasmid DNA (PCR) “Side” cell population (FACS) Empty particles (RNA) Cytokines (ELISA)

Efficiency Infectivity Viability

Transgene expression Titre VCN Cell response

Appearance, Sterility, mycoplasma, Endotoxin, pH, osmolality, adventitious viruses

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