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Home>Testing and Inspection Technology Platform>Virus Clearance Process Validation>Selection of Indicator Viruses
3、 指示病毒选择
Indicator viruses can be classified into three types: "related" viruses (such as human viruses that may be carried by human blood products, including HAV, HBV, HIV, and B19), specific "model" viruses (such as MVM and x-MuLV viruses in CHO expression systems, and BV virus in baculovirus expression systems), and non-specific "model" viruses (such as PRV and Reo3 viruses in CHO expression systems). Priority should be given to selecting viruses that are closely related to potential contaminating viruses. If related viruses are unavailable or unsuitable for in vitro culture, specific "model" viruses can be used as substitutes.
When evaluating the overall virus clearance capability, non-specific model viruses with different characteristics should be selected. These include DNA/RNA, enveloped/non-enveloped, particle size, and viruses that are particularly resistant to physical/chemical treatments. The indicator virus should have a sufficiently high titer, and the selected indicator virus should not pose a biological hazard to operators or the environment.
The validation platform has a rich collection of virus strains, with clear backgrounds, high purity, and titers reaching 8-9 Log10/ml. Table 1 lists the four most commonly used indicator viruses for CHO expression product process validation.
Table 1: Properties of Commonly Used Indicator Viruses in Virus Clearance Process Validation
| Virus Name |
Virus Characteristics |
Testing Method |
Viral Titer Log10/ml |
|
Reo3（呼肠孤病毒） |
双链 RNA 病毒，无包膜，抗性中50-70nm |
TCID50 Q-PCR |
8-9 |
|
MVM（鼠细小病毒 ） |
单链 DNA 病毒无包膜，抗性极高
18-26nm
|
TCID50 Q-PCR |
8.5-9.5 |
| PRV(伪狂病毒) | 双链 DNA 病毒有包膜，抗性中120-200nm |
TCID50 Q-PCR |
8-9 |
|
MuLv （鼠白血病病毒） |
单链 RNA 病毒有包膜，抗性低 80-120nm |
TCID50 Q-PCR |
7.5-8.5 |
|
BV (杆状病毒) |
双链 DNA病毒有包膜 45×275nm |
TCID50 |
8-9 |
|
POL-1 (人脊髓灰质炎I型病毒) |
单链 RNA 病毒无包膜，抗性中 25-30nm |
TCID50 |
8-9 |
|
VSV (水疱性口炎病毒) |
单链 RNA 病毒有包膜，抗性低 70×150nm |
TCID50 Q-PCR |
8-9 |
|
PPV （猪细小病毒） |
单链 DNA 病毒无包膜，抗性高 18-24nm |
TCID50 Q-PCR |
7.5-8.5 |
|
HAdV-5
(人腺病毒5型) |
双链 DNA 病毒无包膜，抗性低
70-90nm |
TCID50 |
8.5-9.5 |
|
BPIV-3 （牛副流感病毒3型） |
单链 RNA 病毒有包膜，抗性低 150-200nm |
TCID50 |
8-9 |
