Rokote Laboratories Finland Oy's intranasal coronavirus vaccine has transitioned from the product development phase to the production phase

​Following the completion of the research and development phase for Rokote Laboratories Finland Oy's FINCoVac 2.1 coronavirus vaccine in early summer, the vaccine has advanced to the next stage in the production process at a designated contract manufacturer. This marks a significant milestone in the vaccine's development.   

Rokote Laboratories Finland Oy demonstrated that the initial production batch of the developed FINCoVac 2.1 vaccine met the specified criteria for quality, safety, and production parameters. It was deemed suitable for production in accordance with Good Manufacturing Practice (GMP), enabling the initiation of the production of the drug batch required for clinical trials of the intranasal coronavirus vaccine.   

​"This achievement is significant for our company. The research and development phase of our coronavirus vaccine production proceeded successfully, and we have taken a significant step forward. The production phase of our vaccine is more straightforward than the preceding preclinical development work, but it still carries its own risks. Our goal is to obtain clinical trial approval from the authorities by the end of the year and commence the first phase of clinical trials," said Tuija Keinonen, CEO of Rokote Laboratories Finland. ​

Multi-stage Production of the Drug Batch

Rokote Laboratories Finland Oy's drug (vaccine) is vector-based, utilizing a safe adenovirus as a carrier. Within the virus vector, the DNA sequence of the coronavirus spike protein has been clo​ned. The GMP-level production process of the virus vector vaccine began with the preparation of a large virus bank called the Master Viral Seed Stock (MVSS). The virus bank has already been prepared by Rokote Laboratories Finland Oy's contract manufacturer in Belgium. The MVSS virus bank has been divided into multiple sub-banks and is stored at -80°C to ensure long-term viability. The MVSS serves as the starting material to produce production-scale drug batches, and it can be used to produce several hundred drug batches. 
 
"The preparation of the MVSS virus bank is part of the risk management in the production process, and it also streamlines production when the starting material for drug batches has been verified as safe and of high quality," said Erkko Ylösmäki, Director of Research and Development. 
 
Currently, the contract manufacturer is finalizing the production of the FINCoVac 2.1 drug batch intended for use in clinical trials. If production proceeds as planned during early autumn, the application for clinical trial approval is intended to be submitted to the authorities by late autumn. 
 
Initiating clinical trials is an official indication to the world of the development work being carried out in Finland on the coronavirus vaccine. 
 
"Clinical trials are reported in a public registry, providing information to authorities, competitors, investors, and interested parties about the stage of our development. Currently, we are at least halfway along the development path, as the most sensitive phase of development is behind us," Keinonen added.

​Further information:

Erkko Ylösmäki 
Research and Development Director, Rokote Laboratories Finland Oy 
erkko.ylosmaki(at)rokote.com 
p. 040 5836604 

​Text: Anni Turpeinen
Image: iStock