Rut Besseling received his PhD from Leiden University. He has 20 years’ experience in physics/chemistry of nanosuspensions, complex fluid behavior and development of analytical instruments, and is (co)author of >50 publications. After several years in pharma, he co-founded InProcess-LSP in 2014, where he leads developments of innovative (Process) Analytical measurement solutions for LifeScience, Chemicals and Pharma. This resulted in 2019 in the launch of novel SR-DLS instrumentation for advanced inline nanoparticle sizing. His interests include optics, spectroscopy, rheology, and applications of (nano)suspensions in the Pharmaceutical and Chemical Industry.
Process Analytics for Nanotherapeutics Manufacturing, Enabled by Novel Inline Nanoparticle Sizing Technology
Tuesday, 14 November 2023 at 14:30
Add to Calendar ▼2023-11-14 14:30:002023-11-14 15:30:00Europe/LondonProcess Analytics for Nanotherapeutics Manufacturing, Enabled by Novel Inline Nanoparticle Sizing TechnologyExtracellular Vesicles and Nanoparticle-based Therapeutics Europe 2023 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
The rise of nanotherapeutics -and nano based products in general- has increased the need for better characterization, understanding and control of nano-particle (NP) suspensions in synthesis and processing. In Pharma this is emphasized by regulatory drives for Quality by Design (QbD) and process monitoring via Process Analytical Technology (PAT). But continuous measurement of NPs like LNPs or liposomes using PAT integrated in the production process, has so far hardly been possible. Specifically, NP size characteristics -critical for endproduct quality- could previously not be measured inline due to the challenges regarding e.g. suspension turbidity and ‘agitation’ for standard methods (e.g. standard Dynamic Light Scattering, DLS). This has been an important barrier in successful development, scale-up and manufacturing of nanotherapeutics. Here I will describe applications of a new non-invasive PAT instrument – the NanoFlowSizer (NFS)- providing continuous, real-time, in-process size characterization of NP suspensions, over a vast range of suspension turbidities and flow conditions. The NFS resolves scattered light signals as function of depth in the suspension (‘Spatially Resolved Dynamic Light Scattering’), which provides the key solution to the turbidity/flow challenges mentioned for inline NP sizing. After a brief technology intro, several examples are described highlighting the NFS’ novel process monitoring capabilities. These include monitoring of solid NP syntheses (SiO2/TiO2/Ibuprofen), pharmaceutical nano-emulsion homogenization, processing of protein solutions and, lastly, continuous manufacturing of liposome formulations, including unique PAT-based automated process control for ‘on target’ production.
Add to Calendar ▼2023-11-13 00:00:002023-11-14 00:00:00Europe/LondonExtracellular Vesicles and Nanoparticle-based Therapeutics Europe 2023Extracellular Vesicles and Nanoparticle-based Therapeutics Europe 2023 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2023-11-14 14:30:002023-11-14 15:30:00Europe/LondonProcess Analytics for Nanotherapeutics Manufacturing, Enabled by Novel Inline Nanoparticle Sizing TechnologyExtracellular Vesicles and Nanoparticle-based Therapeutics Europe 2023 in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
