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Analytical Assay Development & Qualification

Analytics Development

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JOINN Biologics

Analytics Development

Analytics provides the information for the quality of the product itself, as well as the levels of impurities. By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis, or downstream purification by analyzing protein products. 

SubjectCharacteristicsJOINN’s Analytical Methods
Spent MediaExpressions (titer)
Amino Acids
Vitamins
HPLC, biosensor (Octet)
HPLC
HPLC
ProteinsConcentration
Integrity
Heterogeneity
Aggregation
Charge variants
Glycosylation
Thermostability
Binding activity
Viscosity
Turbidity
UV spectrometer
CE-SDS, SDS-PAGE, MassSpec
MassSpec (intact, subunit, peptide mapping)
SEC-MALS, 96-well DLS, Non-reducing SDS Page
Capillary isoelectric focusing (cIEF), HPLC-IEX
Released glycan by HPLC, MassSpec for attached glycan
DSF
Octet, ELISA
Visometer
Vis spectrometer
ImpuritiesEndotoxin
HCP
Protein A
Residual DNA
LAL
ELISA
ELISA
qPCR

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