Gene therapy vector contamination assay
US12152281B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | May 30, 2019 |
| Grant date | Nov 26, 2024 |
| Priority date | — |
| Expiry date | May 30, 2039 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC12Q2600/156
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Certain viral gene therapy vectors are by design unable to replicate in a patient. Nonetheless, during manufacture of viral gene therapy vector, undesirable replication-competent virus (“RCV”) may form due to random mutation or other events. Viral gene therapy vector manufacturers thus assay for the presence of contaminating RCV. Regulatory agencies require this to be done by assaying for serial infection, i.e., transducing target cells with the viral vector, and then lysing the transduced cells, and then mixing the lysate with live assay cells, and then microscopically observing the assay cells to visually determine whether they have been infected with virus. We have tested various alternative approaches, and surprisingly found that digital PCR is not only faster than the prior art approach, but is also over an order of magnitude more sensitive, able to detect, for example, in 3×1010 assay cells, as few as seven (7) replication competent adenoviruses (“RCA”).
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.