Abstract: A METHOD OF MANUFACTURING INACTIVATED VIRAL VACCINE COMPOSITIONS THEREOF ABSTRACT The present invention relates to a method of manufacturing an inactivated viral vaccine that provides desired vaccine wherein complete virus inactivation occurs along with optimum virus recovery, less impurities and said process is amenable to scale up. The present invention envisages a platform process of manufacturing the viral vaccine suitable for the prevention and treatment of monkeypox disease and meets the criterion for the sero-protection in children, adolescents, adults and older population including immunocompromised individuals and pregnant women against monkeypox virus.
CLAIMS
We Claim:
1. A method for manufacturing an inactivated virus, the method comprising:
(i) providing a cell line, a culture media, a buffer and a supplement;
(ii) inoculating the cell line with the virus to form an infected cell line;
(iii) culturing the infected cell line;
(iv) harvesting the infected cells to obtain a harvest;
(v) clarifying the harvest to obtain a clarified virus;
(vi) inactivating the clarified virus to obtain inactivated virus.
2. The method as claimed in claim 1 further comprising steps of:
(i) purifying the inactivated virus;
(ii) splitting the purified virus;
(iii)stabilizing the split virus; and
(iv)sterilizing the stabilized split virus to obtain sterilized inactivated split virus.
3. The method as claimed in any one of claims 1 to 2, wherein the virus is Poxviridae
virus, and wherein the virus is poxvirus selected from small pox virus, monkeypox
virus (MPXV), cowpox virus (CPXV), camelpox virus (CMLV), or vaccinia virus
(VACV), ectromelia virus (ECTV), horsepox virus (HPXV), variola virus (VARV),
rabbitpox virus (RPXV), raccoon poxvirus, skunkpox virus, Taterapox virus, Uasin
Gishu disease virus and volepox virus.
4. The method as claimed in claim 3, wherein the poxvirus is monkeypox virus
including clade I, clade II, clade I with subclade Ia, clade I with subclade Ib, clade II
with subclade IIa, or clade II with subclade II.
5. The method as claimed in any one of claims 1 to 4, wherein the cell line includes vero
cell line, Vero E6 cell, a BSC-40 cell line, a Vero adherent cell line, a Vero
suspension cell line, WHO vero 10-87(ATCC CCL-81) cell line, vero 76 (ATCC
CRL-1587) cell line, vero C1008 (ATCC CRL-1586) cell line, MDCL cell line,
MRC-5 cell line, PER.C6 cell line, HEK293Tan ACE2 Knockout Vero cell, a BHK21 cell, or an MRC-5 cell.
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6. The method as claimed in any one of claims 1 to 5, wherein the cell line is WHO
Vero (ATCC CCL-81) cell line.
| # | Name | Date |
|---|---|---|
| 1 | 202321084956-STATEMENT OF UNDERTAKING (FORM 3) [13-12-2023(online)].pdf | 2023-12-13 |
| 2 | 202321084956-PROVISIONAL SPECIFICATION [13-12-2023(online)].pdf | 2023-12-13 |
| 3 | 202321084956-POWER OF AUTHORITY [13-12-2023(online)].pdf | 2023-12-13 |
| 4 | 202321084956-FORM 1 [13-12-2023(online)].pdf | 2023-12-13 |
| 5 | 202321084956-Proof of Right [30-01-2024(online)].pdf | 2024-01-30 |
| 6 | 202321084956-PostDating-(09-12-2024)-(E-6-300-2024-MUM).pdf | 2024-12-09 |
| 7 | 202321084956-APPLICATIONFORPOSTDATING [09-12-2024(online)].pdf | 2024-12-09 |
| 8 | 202321084956-Proof of Right [12-03-2025(online)].pdf | 2025-03-12 |
| 9 | 202321084956-CORRESPONDENCE-OTHERS [12-03-2025(online)].pdf | 2025-03-12 |
| 10 | 202321084956-COMPLETE SPECIFICATION [12-03-2025(online)].pdf | 2025-03-12 |