In this article, Karen Bossert, vice president of operations at CDMO Particle Sciences, reviews the use of lyophilisation in pharma and the growing market need for this technology, as well as how practical expertise and operational experience help obtain the best results for pharma’s most advanced drug developers.
Iceberg
Managing shelf life and other critical delivery targets
Lyophilisation is a practical, commercially validated method to stabilise formulations and therapeutic molecules. The process relies on the control of pressure and temperature within the lyophiliser to remove liquid from formulations containing thermally sensitive active pharmaceutical ingredients (APIs) or formulation components. The resulting solid exhibits greater stability than the aqueous solution and can be stored for longer periods at potentially higher temperatures compared to its liquid precursor and may include ambient conditions. This technology has been particularly useful for large molecule developers - a growing segment of the pharmaceutical industry. With lyophilisation, fragile biologics no longer require expensive complex logistics such as rigorous cold-chain custody validation regimes and constant documentable refrigeration at the dispensary level.
The market’s growing need
As API and formulation stability challenges become more common, growing numbers of pharmaceutical and biotech manufacturers view lyophilisation as an enabling technology for the next generation of therapeutics.