AUSTAR Compliance Consultancy Service has been awarded the validation consultancy services contract for the company's recombinant protein COVID-19 vaccine project. The service standard is WHO GMP, EU GMP and NMPA GMP, and the scope of service includes new plants and utilities, process equipment, computerised systems, auxiliary equipment, process cleaning and other validation consultancy services.
Currently, AUSTAR Compliance Consultancy Service project team is working with the client project team to drive the full implementation of the project with good regulatory compliance, validation and project management capabilities.
"Our client is one of the oldest biological products research institutes in China and is mainly engaged in the production, research, development and operation of preventive products, therapeutic products, diagnostic reagents and other biological products," Austar stated.
A new frontier
As a late-emerging type of vaccine, a recombinant protein vaccine still has great room for development. A recombinant vaccine is a vaccine produced through recombinant DNA technology. This involves inserting the DNA encoding an antigen (such as a bacterial surface protein) that stimulates an immune response into bacterial, yeast, or mammalian cells, expressing the antigen in these cells, and then purifying it from them. The recombinant protein vaccine technology is mature, and suitable for large-scale production.
The production does not require facilities with high biosafety levels since the process does not involve live viruses or other infectious materials, with faster production speed, easy storage and distribution.
In February 2022, a research paper published in the journal Cell Discovery by the Chinese Institute of Biological Sciences showed that the Generation II recombinant protein COVID-19 vaccine showed potent protection against the prototype strain and multiple variants.
