Zoonbio has a second-level biological laboratory in Beijing, which is designed and managed strictly in accordance with GLP specifications. The laboratory is equipped with a complete set of instruments and equipment for virus inactivation/clearance verification, including a number of biosafety cabinets, a number of AKTA purification systems and ultracentrifuges.
The detection methods have been validated by methodology.
More than 600 viral clearance validation studies have been conducted, involving product types including antibodies, proteins and vaccines. Seven products have been successfully declared (success rate is 100%) and 16 products are being validated.
There are biosafety level II laboratories in accordance with the national regulations and equipments and instruments required for virus verification experiments.
Most of the indicative viral titers can reach above 8 log10 TCID50.
(1)Process development stage.（Optional）
(2)Clinical application for new drugs(IND).(Compulsory)
(3)Application for Biological Products License（BLA）.（Compulsory）
STEP
Determination of reducing process model.
Determination of Indicating Viruses.
Pre-experiment.
Formal experiment.
| virus name | X-MuLv | PRV | Reo-3 | MVM | VSV | Baculovirus | Rhabdovirus | TNCL |
| viridae | retrovirus | herpes virus | reovirus | parvovirus | vesicular virus | baculovirus | endogenous virus | endogenous virus |
| genotype | ssRNA | dsDNA | dsRNA | ssDNA | ssDNA | DNA | RNA | RNA |
| envelope | yes | yes | not | not | yes | yes | yes | not |
| size(nm) | 80-110 | 120-200 | 60-80 | 18-24 | 70-175 | 21*260 | 79*178 | 29-35 |
| test method | TCID50 and QPCR | TCID50 | TCID50 | TCID50 and QPCR | TCID50 | TCID50 and QPCR | QPCR | TCID50 and QPCR |
| applicable | not applicable |
1.Recombinant or hybridized animal eukaryotic cells, expressed or secreted after culture (e.g. recombinant CHO cells, human or animal hybridoma cells, expressed or secreted interferons, monoclonal antibodies, recombinant proteins, vaccines, etc.) 2.Therapeutic biological products (such as biological products extracted from animal cells, tissues and body fluids) prepared directly from raw materials of animal tissues by extraction and purification. |
1.Biological products expressed or secreted by yeast cells. 2.Inactivated vaccines, live vaccines, live loads of genetic engineering and other products. |
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