Methods of detection and removal of rhabdoviruses from cell lines
The present disclosure relates to compositions, methods, mixtures, and kits for detecting the presence of, and for removing, a virus from a product produced in an insect cell. The disclosure also relates to proteins, peptides, polypeptides, drug substances, biological products, vaccine antigens, and virus-like particles that are produced in an insect cell and that are free or substantially free of a virus. The disclosure also relates to compositions, methods, assays, and kits for detecting a rhabdovirus in a sample.
1. A method of producing a biological product using a rhabdovirus-free Sf9 or Sf21 insect cell, or a rhabdovirus-free cell passaged therefrom, wherein the method comprises the steps of:
a) providing the rhabdovirus-free Sf9 or Sf21 insect cell, or the rhabdovirus-free cell passaged therefrom; and
b) producing the biological product in said rhabdovirus-free cell.
2. The method of claim 1 , wherein the insect cell is an Sf9 cell.
3. The method of claim 2 , wherein the Sf9 cell is derived from the cell line deposited as ATCC CRL-1711.
4. The method of claim 1 , wherein the insect cell is an Sf21 cell.
5. The method of claim 1 , wherein the biological product is for therapeutic or diagnostic purposes.
6. The method of claim 1 , wherein the biological product is a protein, peptide, drug substance, virus-like particle (VLP), antibody, growth factor, polysaccharide, nucleic acid, virus, or vaccine antigen.
7. The method of claim 1 , wherein the biological product is DNA.
8. The method of claim 1 , wherein the biological product is RNA.
9. The method of claim 1 , wherein the biological product is a recombinant virus for gene therapy.
10. The method of claim 1 , wherein the biological product is a therapeutic protein or an enzyme.
11. The method of claim 1 , wherein the biological product is a Calicivirus VLP.
12. The method of claim 1 , wherein the biological product is a Norovirus VLP.
13. The method of claim 1 , wherein the biological product is a protein and the protein is glycosylated.
14. The method of claim 1 , wherein the insect cell is free of a nucleotide sequence having at least 70% homology to SEQ ID NO:1.
15. The method of claim 1 , wherein the insect cell is free of a nucleotide sequence comprising the sequence according to SEQ ID NO: 1.
16. The method of claim 1 , wherein the biological product is a protein.
17. The method of claim 1 , wherein the biological product is a peptide.
18. The method of claim 1 , wherein the biological product is a drug substance.
19. The method of claim 1 , wherein the biological product is a virus-like particle (VLP).
20. The method of claim 1 , wherein the biological product is an antibody.
21. The method of claim 1 , wherein the biological product is a growth factor.
22. The method of claim 1 , wherein the biological product is a polysaccharide.
23. The method of claim 1 , wherein the biological product is a nucleic acid.
24. The method of claim 1 , wherein the biological product is a virus.
25. The method of claim 1 , wherein the biological product is a vaccine antigen.
26. The method of claim 1 , wherein the cell is comprised in a baculovirus-insect cell expression system.
27. The method of claim 1 , wherein the cell is a rhabdovirus-free cell passaged from a rhabdovirus-free Sf9 or Sf21 insect cell.
28. The method of claim 1 , wherein the cell is a rhabdovirus-free cell passaged from a rhabdovirus-free Sf9 cell, wherein the Sf9 cell is derived from the cell line deposited as ATCC CRL-1711.
29. A method of producing a biological product in an insect cell, the method comprising the steps of:
a) providing the insect cell,
b) confirming the absence of a rhabdovirus in the insect cell, and
c) producing the biological product in the insect cell,
wherein the rhabdovirus comprises a sequence having at least 95% homology to SEQ ID NO: 1.