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 2002) | ATCC-produced lot 70070371 – QC 2025 | |
|---|---|---|
| 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 | 5.91×1011 particles/mL (2002 value of 5.8×1011 particles/mL) | 6.23×1010 particles/mL |
| Genome copy number | 2.07×1010 genome copies/mL as determined by ddPCR in triplicate with 9 replicates | 3.90×109 genome copies/mL as determined by ddPCR in triplicate with 9 replicates |
| Infectious titer (TCID50/mL) in HEK 293 Cells (CPE Read-Out) | 2.0×1010 TCID50/mL | 3.1×109 TCID50/mL |
| Infectious titer in HEK 293 Cells (LumaCyte Radiance Absolute Titer) | 7.4×109 IU/mL | 1.1×109 IU/mL |
| Authentication | Next-generation sequencing was performed. The ARMWG lot was 99.92% identical with the reference sequence (AY339865.1) | Next-generation sequencing was performed. The new lot was 99.15% identical with the reference sequence (AY339865.1) |
| Bioinformatics analysis | 4 variants were detected relative to the following genome as a reference sequence: AY339865.1 (Adenovirus) from GenBank. | 4 variants (identical to VR-1516 Lot 001506) were detected relative to the following genome as a reference sequence: AY339865.1 (Adenovirus) from GenBank. |
| Adventitious agents (NGS and IDEXX panel) | Not tested (Free of adventitious agents) | None detected |
| Sterility [AST bottle (aerobic) at 32.5°C, 14-day incubation] | Not tested (Free of adventitious agents) | None detected |
| Sterility [iNST bottle (anaerobic) at 32.5°C, 14-day incubation] |
Not tested (Free of adventitious agents) | None detected |
| Mycoplasma (direct and PCR-based) | Not tested (Free of adventitious agents) | None detected |
| Endotoxin | < 0.15 EU/mL | < 0.15 EU/mL |
| Residuals - HEK 293 Host Cell Protein (ELISA) | 0.11 ng/mL (2002 value of 18 ng/mL) | 63.05 ng/mL |
| Residuals - A260 to A280 ratio | 1.60 (2002 value of 1.37) | 1.44 |
| Residuals - BSA |
0.56 ng/mL (2002 value of <0.5 ng/mL) | 3.45 ng/mL |
| Fill volume | 0.5 mL | 0.5 mL |
| Storage | -70°C or colder | -70°C or colder |
| pH | 8.1 | 7.4 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
IU/mL = Infectious units per mL
EU = Endotoxin units
ddPCR is a registered trademark of Bio-Rad Laboratories, Inc. LumaCyte is a registered trademark of LumaCyte, LLC.
