Article: The importance of real-time nanoparticle size analysis

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Published: 23 February 2023

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The pharma industry must have total control over the production processes of its high-quality products being compliant with stringent demands and regulations. This could cost enormous amounts. So, they need highly efficient and sophisticated Process Analytical Technologies (PAT) which enable continuous insight into process performance in real time.

Yet, something that hinders nanoparticle applications from reaching their full potential is a lack of adequate PAT solutions for monitoring particle size and size distribution in the nanoscale regime. It was recognised by health agencies that one of the greatest challenges in bringing new nanomedicines to the market is accurately determining their particle size during manufacturing.

No Real Solutions Available?

For non-solid products, direct inline (under flow) measurement of nanoparticle size and distribution is crucial to ensure the quality of routine production. Yet, there are no such inline systems currently on the market since the release in 2019 of InProcess-LSP’s NanoFlowSizer technology.

Sampling procedures are required for the technologies which are now utilised (mostly Dynamic Light Scattering) and, in most cases, off-site laboratory analysis and sample treatment (quiescent conditions created, diluted, etc.), which presents severe problems.

NanoFlowSizer

To overcome the limitations of conventional DLS for Process Analytical Technologies, InProcess-LSP developed a new innovative technology: Spatially Resolved Dynamic Light Scattering (SRDLS). SR-DLS allows particle size characterisation in process flow and is able to measure highly turbid suspensions without dilution. In 2019 InProcess-LSP has fully released the NanoFlowSizer as the only TRUE inline particle size measurement technology.

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