Meeting the need for analytical versatility in RNA and LNP drug development
Drug development requires many capabilities and specializations, such as process development, process optimization, and formulation scale of SCPI, RNA, and LNP technologies. That’s why researchers sometimes reach out to people like Dr. Nga Vo, Senior RNA Research Scientist at CPI. Beyond her research in these areas and collaboration on R&D projects with institutions such as Innovate UK, commercial clients come to her when they need a certain formulation optimized or scaled up.
Dr. Vo works with all kinds of samples, so she needs versatile instruments with high sensitivity to analyze any sample her clients bring in. To fulfill this function, CPI uses both the Zetasizer Nano and Zetasizer Ultra.
We had the opportunity to meet Dr. Vo and discuss her experience with the Zetasizer in the context of CPI’s Intracellular Drug Delivery Centre and RNA Centre of Excellence. We asked why CPI chose these instruments, how they perform, and what her experience has been so far.
The challenge of variability
In Dr. Vo’s work, the Zetasizer’s principal function is determining the particle size, hydrodynamic diameter, polydispersity, and zeta potential of nanoparticles in the analyzed samples. These characteristics are critical quality attributes (CQA) for the effectiveness of drug formulations. Dr. Vo’s work is crucial in ensuring that a formulation remains effective when its process parameters are changed – for example, when production is scaled up from lab-scale batches to clinical supply quantities.
The key challenge of this work is variability: “The measurements we need to take all depend on the project,” Dr. Vo says. “A customer might come in with RNA and ask us to encapsulate the RNA into their LNP and follow that up with some in vitro study. We’ll do that by following the approach of doing the encapsulation bit by bit, checking with the Zetasizer at every step. The CQAs we’re checking for will be tailored to the needs of the client, but this approach will be the same.”
The benefits of the Zetasizer’s versatility
CPI chose the Zetasizer Nano and Zetasizer Ultra because they found these instruments best met their technical and financial requirements. For Dr. Vo, the Zetasizer’s greatest value lies in its ease of use and versatility. These strengths are understandably vital in a context where every client or R&D project might involve completely different objectives, formulations, and CQAs.
Dr. Vo explains. “I particularly like the quality report that quickly gives you advice on how to improve your result, and I’ve found the technical support team very positive: they’re always ready to provide helpful advice about the equipment and results interpretation.”
Experience with Zetasizer models
Dr. Vo said she enjoyed the increased performance and reliability of the Ultra, adding that its step-by-step SOP is very clear and easy to follow. In particular, the Ultra provides very good reproducibility, for homogenous formulations especially.
For more complex cases like polydisperse samples, the extensive experience of Malvern Panalytical’s technical support comes to the fore. For example, Technical Support Manager Michael Kaszuba wrote an application note to guide Zetasizer users through measuring dispersant viscosity in polydisperse samples.
These insights are made possible thanks to the partnerships we develop with those who use our instruments. Our deepest thanks to Dr. Vo for sharing her experiences and insights to help us improve the Zetasizer even further!
Want to know whether the Zetasizer Advance is the right instrument for your needs, and which model would suit you best? Head over to the product page!
Further Readings – Not to miss!
- Zetasizer Masterclasses on Best Practice For Method Development In Pharma QC : Watch recordings
- Gain access to exclusive handouts here
- Everything you need to know to choose the right instrument – Access Guidebook here