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Residual Host Cell DNA (qPCR) - HEK293

Residual HEK 293 Host Cell DNA Quantitative Impurity (R&D)

Mycoplasma MycoSEQ

Mycoplasma Detection by MycoSEQ (R&D)

Genomic Titer (dPCR)

Adeno-Associated Virus Vector Genome Titer Assay by Digital PCR (R&D)

Endotoxin (Endosafe)

USP <85> Inhibition/Enhancement verification and Bacterial Endotoxin using Endosafe nexgen-PTS (GMP)

Bioburden

Bioburden Testing / Microbial Enumeration (GMP)

Appearance

Appearance according to the USP (GMP)

pH

USP <791> Determination of pH (GMP)

Osmolality

USP <785> Analysis of Osmolality Using the OsmoTECH XT (GMP)

CE-SDS

Purity by CE-SDS and Capsid Protein Ratio for Adeno-Associated Virus (AAV) (R&D)

HPLC-SEC _MaLs

Aggregation by Size Exclusion Chromatography with Multi Angle Laser Light Scatter (SEC-MALs) (R&D)

ELISA - Host Cell Protein (HEK293)

Residual HEK293 Host Cell Protein ELISA (R&D)

ELISA - Capsid ID (serotype specific)

Adeno-Associated Virus (AAV) Capsid Identity by ELISA (R&D)

Sequencing - Plasmids