One of the main benefits of using Nuvonis fully tested GMP Vero cells is the unparalleled speed towards clinical trials.
A case example from one of our customers, hVIVO:
- First contact with Nuvonis in July 2020, due diligence, contracting, provision of GMP Vero cells and protocols, as well as full documentation
- Production of GMP material in November 2020
- Clinical trial study started in March 2021
- First publication of data in early 2022
This shows that the use of Nuvonis GMP Vero cell banks that are fully tested according to ICH guidelines offers an extremely fast and efficient route to bring vaccines or viruses into clinical evaluation.
UK-based hVIVO Services Limited produced two different viral strains of SARS-CoV-2 in Nuvonis Vero cells under GMP conditions, a Wuhan-like D614G virus and a Delta strain.
This virus was used as a challenge virus in a human viral challenge study in healthy adults in the UK, which was initiated in 2021 and is ongoing, currently with the subjects in the follow-up phase.
Further challenge studies are underway, in which previously infected and vaccinated
volunteers will be challenged with escalating inoculum doses (ClinicalTrials.gov identifier NCT04864548) and/or viral variants to investigate the interplay between virus and host factors that influence clinical outcome.
First publication of the data from the study was published earlier this year in Nature Medicine.
These studies will optimise the platform for potential use in the rapid evaluation of vaccines,
antivirals and diagnostics by generating efficacy data early during clinical development and avoiding the uncertainties of studies that require ongoing community transmission.