Genomic Titer by digital droplet PCR for AAV Vectors containing SV40 polyA signal

Genomic Titer by digital droplet PCR for AAV Vectors using Client Specific Primer and Probes

Genome Copy Titer using qPCR

rAAV Infectious Titer Assay Targeting SV40 ploy A – TCID50 / ddPCR or qPCR

rAAV Infectious Titer Assay Targeting Customer specific targets – TCID50 / ddPCR

Sedimentation Velocity Analysis of Adeno-associated Virus (AAV) using Analytical Ultracentrifugation

Viability and Recovery of Cell Cultures

Protein Concentration using the Micro BCA Protein Assay

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

Purity by SDS-Page and Capsid Protein Ratio for Adeno-Associated Virus (AAV)

Aggregation by Size Exclusion Chromatography with Multi Angle Laser Light Scattering (SEC-MALs)

Particle Size by Dynamic Light Scattering Analysis

Adeno-Associated Virus (AAV) Capsid Identity by ELISA

Quantification of Residual Host Cell DNA using qPCR

Quantification of Residual DNA using qPCR Kanamycin Gene

Quantification of Residual DNA using qPCR Ampicillin Gene

Quantification of Residual E1A DNA using qPCR

Quantification of Residual 18s DNA 3 amplicon using qPCR

Quantification of Residual RepCap Plasmid using qPCR

Quantification of Residual Helper Plasmid using qPCR

Residual Host Cell Protein (HEK293) by ELISA

Residual Endonuclease Detection

Residual Bovine Serum Albumin (BSA)

Residual Affinity Ligand by ELISA

Residual Triton X-100 by HPLC

Residual PEI

Replication Competent AAV (rcAAV)

DNA Sequencing by Sanger Sequencing

Determination of pH, USP <791>

Appearance according to the USP <790>

Genomic Identity by Restriction Enzyme Digestion

Osmolality, USP <785>

Sterility Testing, USP/ EP / 21 CFR 610.12 (Direct immersion)

Bacteriostasis and Fungistasis Final Product (Direct immersion)

Endotoxin – USP BET / LAL Kinetic Chromogenic Assay (Endosafe)

Sub-visible particles, USP <788> Particulate Matter Light Obscuration Method (GMP)

USP <697> and EP 2.9.17 Determination of Extractable Volume in Containers (GMP)

Container Closure Testing

Testing for Agar Cultivable and Non-cultivable Mycoplasmas including Mycoplasmastasis (USP/EP)

Mycoplasma Detection by MycoSEQ

In Vitro Assay for Adventitious Virus – 28 day, MRC-5, Vero and HEK-293 cells