Advances in biotechnology have led to a new generation of vaccine treatments entering development and trial. These innovations include the use of genetically modified organisms and vaccines based on mRNA, where human cells are programmed to develop antibodies against specific diseases. While these vaccines appear new to the general public, research dates back several decades.
As with any pharmaceutical development, there are technical challenges and regulatory hurdles. Balanced with the possibility of the types of serious illnesses that can be addressed, a careful path needs to be followed in terms of meeting regulatory expectations and getting products to market speedily.1
The types of issues that need to be assessed and planned for include meeting CGMP requirements, process validation, comparability, stability, post-approval changes, release testing, and packaging, each of which is connected to the manufacturing and quality control of vaccines. This article looks at the complexities around mRNA vaccines and how they are addressed. The time-to-market will be based on how effectively pharmaceutical companies address the developmental challenges.
Sandle, T. (2022) mRNA Vaccines: Key Considerations For Development & Manufacturing, BioProcess Online, at: https://www.bioprocessonline.com/doc/mrna-vaccines-key-considerations-for-development-manufacturing-0001
Also published in Outsourced Pharma: https://www.outsourcedpharma.com/doc/mrna-vaccines-key-considerations-for-development-manufacturing-0001
Also published in Cell & Gene: https://www.cellandgene.com/doc/mrna-vaccines-key-considerations-for-development-manufacturing-0001
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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