Jeong Jin-hyeok, associated director of Aseptic Filling, at Samsung Biologics, examines the lessons learned following the onset of COVID-19 and highlights how CDMO flexibility is helping to hail in an era of new therapeutic modalities.
Key insights:
- The COVID-19 pandemic highlighted three key areas that manufacturers must carefully consider when working with a relatively new technology: fill-finish capabilities, cold chain capabilities, and building a familiarisation with the product.
- Cold chain capabilities are relied upon heavily for mRNA drug development, allowing for shortened timelines, which were essential to bring vaccines to Phase I and Phase II clinical trials on time when vaccines were in an urgent demand.
- Considerations such as; freezing and storage, primary packaging and validation need to be considered when handling new drug modalities.
In rapid reaction to the COVID-19 pandemic, pioneering drug developers introduced a novel drug modality worldwide in the form of mRNA vaccines. The success of the global vaccine roll-out was facilitated in part through the efforts of contract development and manufacturing organisations (CDMOs) that quickly adapted their capabilities to support mass production.