| Assay number | Test | Verbal result after |
| BT 403 |
Assay for Viral Contaminants using Embryonated Eggs
- Assay in compliance with European and US guidelines for mammalian cell lines.
- Inoculation of embryonated eggs by multiple routes followed by passages.
- Concurrent positive and negative controls.
| 5 weeks |
| BT 403A |
Test for extraneous agents in viral vaccines using Embryonated Eggs
- Assay in compliance with FDA guidelines for the production of viral vaccines for the prevention and treatment of infectious diseases.
- Neutralization procedures if required.
- Inoculation of embryonated eggs by multiple routes followed by passages.
- Concurrent positive and negative controls.
| |
| BT 404A |
Assay for Viral Contaminants using Rodents
- Inoculation of adult mice, newborn mice and guinea-pigs by multiple routes.
- Observation for clinical symptoms of viral infection.
| 4 weeks |
| BT 404B |
Assay for Viral Contaminants using Adult and Newborn Mice
- Inoculation of adult mice and newborn mice by multiple routes.
- Observation for clinical symptoms of viral infection.
| 4 weeks |
| BT 405 |
Extended Assay for Viral Contaminants using Indicator Cell Lines
- Inoculation into an extended series of indicator cell lines, followed by a passage (amplification step).
- A series of five cell lines are included, aimed at the detection of a broad array of viruses infectious for different mammalian cell lines.
- Tests for hemagglutinating and hemadsorbing viruses.
- Concurrent positive and negative controls.
| 4 weeks |
| BT 406A |
Assay for Viral Contaminants using 3 Indicator Cell Lines (Mouse)
- Inoculation onto three indicator cell lines aimed at the detection of mouse specific viruses.
- Procedure identical to Assay #BT405.
| 4 weeks |
| BT 406B |
Assay for Viral Contaminants using 3 Indicator Cell Lines (Human)
- Inoculation onto three indicator cell lines aimed at the detection of human specific viruses.
- Procedure identical to Assay #BT405.
| 4 weeks |
| BT 406C |
Assay for Viral Contaminants using 3 Indicator Cell Lines (Hamster)
- Inoculation onto three indicator cell lines aimed at the detection of hamster specific viruses.
- Procedure identical to Assay #BT405.
| 4 weeks |
| BT 406D |
Assay for Viral Contaminants using 3 Indicator Cell Lines (Bovine)
- Inoculation onto three indicator cell lines aimed at the detection of bovine specific viruses.
- Procedure identical to Assay #BT405.
| 4 weeks |
