The life sciences division of Germany’s Merck, MilliporeSigma, has entered into a partnership with South Korea’s International Vaccine Institute (IVI) in order to develop more robust and scalable vaccine manufacturing processes.
The collaboration is focused on conjugated polysaccharide vaccines which currently employ the use of organic solvents and detergents within the manufacturing process, director of Merck’s Worldwide Vaccine Initiative Priyabrata Pattnaik told Biopharma-Reporter.com.
“The regulatory landscape is changing, and among these changes are environmental concerns around organic solvents and their disposal,” he said. “The goal of this collaboration is to develop a standardised, next generation process that will allow us to avoid the use of these organic solvents and detergents.
“We aim to create an environmentally sustainable way to produce vaccines that are high quality, low-cost, and available to people who need them the most.”
Regulatory changes
Pattnaik also spoke about “positive moves in the regulatory landscape,” saying the Quality by Design (QbD) being used to develop monoclonal antibodies is being slowly adopted in vaccine manufacturing.
“Vaccines are becoming better characterised and we have seen increasing transparency from regulatory bodies with regard to evaluating the quality of vaccines and how manufacturing impacts quality,” he said.
“There is a lot that needs to be addressed, but regulatory is catching up to the technology trends and the situation looks very promising.”
Vaccine makers
And such technology trends are crucial for vaccine makers, he continued
“New generations of technology platforms all require innovation – either directly or indirectly, and anyone who isn’t innovating will be left behind.”
Traditional large vaccine manufacturers are generally partnering with smaller companies and emerging biotechs with innovative vaccine platforms, he added, looking to integrate these into their manufacturing processes.
“With developments in gene therapy and gene editing, viral vectors, mRNA-based vaccines, and new vaccine delivery systems, innovation is certainly happening.”