BRAVE PARTNERS. PIONEERS. VISIONARIES.
Is your research or your production limited by your method of particle characterization? Do you want to get much deeper insights into the composition and behavior of your particles? OF2i is already used by the following partners in their groundbreaking research and for optimized production processes. Take a closer look at these early use cases to get a taste of the potential of OF2i and get in touch to talk about how we can help you raise the level of your particle analysis.
Researchers at a European university investigating the leaching of nanoplastics out of plastic bottles into drinking water were unhappy with time-consuming particle counting methods which were still not sensitive enough to detect the very low numbers of nanoplastic particles in their samples.
They came to BRAVE Analytics to see if OF2i could detect plastic nanoparticles only present in extremely low concentrations.
The BRAVE B-Curious for ultra-low concentration determination was used.
In the experiment, the researchers sterilized the bottles and performed various cleaning procedures using 20 nm filtered ultrapure water (type 1). Immediately after this cleaning procedure, the OF2i measurement was performed as no further sample preparation was required. After taking the base-line concentration the research team measured the particle concentration in the glass and plastic bottles. Measurements took approx. 10 minutes.
Interestingly, they discovered different contaminations after different cleaning procedures. They repeated the procedure with different plastic bottles and could see a significant decrease in particle concentration after 3 cleaning steps. The nanoparticle concentration detected in glass bottles was also measured and plotted together with the reference filtered water.
One of the top-ten global pharmaceutical concerns was looking for a more efficient alternative to offline QC testing on their total parenteral nutrition products. These oil-in-water emulsions must comply with strict regulations regarding particle size and particle size distribution.
There was as yet no true PAT solution for monitoring this production process and the time lag inherent with manual quality control testing in the laboratory brings the possibility of producing out-of-spec formulations, with resulting high costs. The benchtop device the team were using for PSD determination was based on an ensemble-method technology which delivered unreliable results influenced by different parameters such as viscosity and concentration. The testing was a tedious procedure including manual operation and dilution, another possible source of error.
The best-case scenario would be a move to online monitoring and towards real-time release testing for these liquid formulations.
The challenges in this case are:
The BRAVE B-Continuous online device (including continuous and automated online sample preparation unit) was installed in a pilot plant at the company premises. The homogenization pilot plant consists of two homogenization steps; by applying high pressure the particle size gradually decreases. After the first step particle size is reduced from 3 µm to approximately 0.3 µm. The process analyzer (BRAVE B-Continuous) is connected to the process connection positioned after the first step to measure the efficiency of this homogenization procedure. It continuously monitors PSD distribution and automatically evaluates and collects data such as D-values which are used to evaluate the efficiency of the process. The plug-and-play setup can also be easily moved to other measuring points to monitor the efficiency of other process steps.
Professor Tobias Madl at Medical University of Graz, Austria, is researching (dys)regulation and the drug targeting of biomolecular condensate formation. Distortions in these condensates indicate age-related diseases such as cancers, Alzheimer’s and senile dementia. He was looking for alternative methods to study condensate size distributions and time evolution and came to BRAVE Analytics for advice. Without a thorough understanding of the molecular processes involved in early-stage condensate formation it is impossible to plan a strategy to improve existing models and discover how and when drugs are administered most effectively.
Professor Madl used the BRAVE B-Curious module for time-resolved sizing to achieve dynamic particle characterization on only 100 µl sample volume. The sample composition was a buffer with 6 µM protein and various amounts (from 0.02 µM to 0.2 µM) of RNA added.
The measuring results clearly showed the kinetics of these LLPS processes (see excerpt) and allowed comparison of the formation of particles in the presence of different RNA concentrations.
The results of measurements will soon be published and will be part of a number of PhD thesis.
Benefits of OF2i in the study of biomolecular condensate formation:
Are you frustrated by the limits of conventional particle characterization methods and what this means for your research? Unlike other light scattering methods, the OF2i method of particle characterization is particularly suited to:
The BRAVE B-Curious lab device is already at work in research into liquid-liquid phase separation processes. We believe BRAVE B-Curious would be a great asset in other biotechnological and biomedical fields. We look forward to hearing from you if you are interested in getting groundbreaking insights into particle composition and behavior on the following:
The OF2i method is both sensitive to single particles and also the absence of particles. Take, for example, 20 nanometer filtrated water. OF2i measurements on nanofiltrated water will detect any particles above 20 nm remaining in the sample, even if the concentration is extremely low, e.g. only a few particles per milliliter. An interesting study in this field was carried out using OF2i to detect nanoplastic particles leached into filtered water with the results confirming how sensitive OF2i is when detecting ultra-low concentrations.
By the beginning of 2024, BRAVE Analytics will launch its BRAVE B-Continuous online device with OF2i inside. This online sensor is for:
As BRAVE B-Continuous uses the OF2i method and provides the same measuring protocols as BRAVE B-Curious, you can easily upscale your research into production and always have compatible results.
BRAVE B-Continuous is already being tested by a global pharmaceutical concern in its pilot plant. This test installation is for monitoring the exact composition of nanoemulsion nutritional admixtures for quality control, process optimization and more efficient compliance with regulations.
PARTICLE MEASUREMENT
As a partner in the MOZART project (MOZART for safe & sustainable by-design metallic coatings & engineered surfaces (RIA)), we received funding from the European Commission as part of the EU Horizon 2020 program.