The Human Adenovirus Type 5 Reference Material (ATCC VR-1516) is now available. All new stocks of the reference material will be produced and authenticated at ATCC instead of by an outside working group—that means no more supply limitations when ordering!
Because of the necessary differences in manufacturing between new lots and the original 2001 production, there are a few changes to the reference material as compared to previous stocks. We have provided a comparison below for reference.
Table 1: Bridging study of Human Adenovirus Type 5 reference material produced by ARMWG and ATCC
| ARMWG-produced lots (QC 2024) | ATCC-produced lot (2024) | |
|---|---|---|
| Description | Purified Human Adenovirus Type 5 Reference Material | Purified Human Adenovirus Type 5 Reference Material |
| Origin | Master virus bank derived from plaque-purified Human adenovirus 5 (ATCC VR-5; wild type) | Master virus bank derived from plaque-purified Human adenovirus 5 (ATCC VR-5; wild type) |
| Host cells | HEK 293 cells | HEK 293 cells |
| Particle concentration (Inogen Method) | 5.43×1011 particles/mL | 3.74×1010 particles/mL |
| Genome copy number | 7.66×109 GC/mL genome equivalents per mL as determined by ddPCR™ in triplicate with 9 replicates | 1.41×109 genome equivalents per mL as determined by ddPCR™ in triplicate with 9 replicates |
| Infectious titer (TCID50/mL) in HeLa Cells (CPE Read-Out) | 5.00×109 TCID50/mL | 1.58×107 TCID50/mL |
| Infectious titer (TCID50/mL) in HEK 293 Cells (PCR Read-Out) | 2.81×109 TCID50/mL | 2.81×108 TCID50/mL |
| Viral Kinetics Time to IC50 (post-infection) | 25.5 hours | 42.1 hours |
| Authentication | Next-generation sequencing was performed. The ARMWG lot was 100% identical with the reference sequence (AY339865.1) | Next-generation sequencing was performed. The new lot was 100% identical with the reference sequence (AY339865.1) |
| Bioinformatics analysis | 3 variants under 10% were detected relative to the following genome as a reference sequence: AY339865.1 (Adenovirus) from GenBank. | 2 variants under 10% detected relative to the following genome as a reference sequence: AY339865.1 (Adenovirus) from GenBank. |
| Adventitious agents | Free of adventitious agents | Free of adventitious agents |
| Endotoxin | Endotoxin was < 0.15 EU/mL | Endotoxin was < 0.15 EU/mL |
| Residuals - HEK 293 Host Cell Protein (ELISA) | 3.7 ng/mL | 43.3 ng/mL |
| Residuals (A260 to A280 ratio) | 1.61 | 1.81 |
| Residuals - BSA |
0.26 ng/mL | 2.1 ng/mL |
| Pierce BCA protein assay | 223.4 µg/mL | 77.6 µg/mL |
| % HEK 293 Host Cell Protein | 0.002% | 0.056% |
| Fill volume | 0.5 mL | 0.5 mL |
| Storage | -70°C or colder | -70°C or colder |
| pH | 8.0 at room temperature | 7.5 post-thaw (using a pH strip) |
| Manufacturing standard | GMP | ISO 9001 |
NGS = Next-generation sequencing
BSA = Bovine serum albumin
ARMWG = Adenovirus Reference Material Working Group
EU = Endotoxin units
