Chromatography 11 Improving precision in nanoparticulate formulation dispensing
Biotech Fluidics has successfully developed and implemented an innovative combined micro flowmeter and degasser system to improve the dispensing of a nanoparticulate formulation for a leading medical technology company.
To ensure precise spray coating of the pharmaceutical formulation onto a medical device, the contract manufacturing organisation (CMO) enlisted Biotech Fluidics for their expertise in turnkey fluidics systems and degassing solutions.
Biotech Fluidics’ Micro Flow Meter, optimised for flow rates ranging from 100 nl to 80 µL/min with a high resolution of 1 nl/min, proved to be the ideal tool for monitoring the accuracy and consistency of low-volume liquid dispensing.
Robin Oz, Project Manager at Biotech Fluidics, explained: “While flowmeters are available for lab-scale processes, they often fall short in monitoring micro and nanoscale liquid volumes. Our Micro Flow Meter, a non-invasive device offering real-time flow data, was perfect for ensuring the precision of the pharmaceutical spray coating. Although our flowmeter is calibrated for aqueous solutions, we collaborated with our customer to develop a robust calibration for acetone, the solvent used in the manufacturing process.”
Dr Oz added: “Microbubble formation, which compromised dosing precision, was a challenge we addressed by integrating a high-performance degasser into the process line. Our DEGASi® 100 µL/min, effectively resolved this issue.”
He concluded: “After demonstrating the reliable operation and monitoring accuracy of the micro flowmeter and degasser setup, our client has placed an order for 32 systems.”
More information online:
ilmt.co/PL/OkWM and
ilmt.co/PL/LLlR 62853pr@reply-direct.com Plus Nano inline degasser, with an internal volume of just 25 µl and optimised for fluid flows up to
Robust bioinert columns for a new level of recovery
Ion exchange chromatography (IEX) is widely used for Bio QC methods, especially for charged variant analyses. Sensitive substances like oligonucleotides tend to interact with column hardware, even with quite inert IEX standard hardware made of PEEK. Adsorption of the analytes on the surfaces lead to peak tailing, carryover, and reduced recovery.
YMC meets this special challenge with the recently launched YMC Accura columns. They feature a bioinert surface coating of the column body and frits. The robust bioinert coating used on YMC Accura hardware is 130 to 320-fold thicker compared to similar hardware concepts. Permanent inertness against sensitive substances is ensured. Therefore, YMC Accura columns can even be used for the analysis of sensitive substances without pre-conditioning.
The non-porous hydrophilic polymer beads of the BioPro IEX stationary phases enable exceptionally high efficiencies and high throughput analyses. Even small sample variations can be easily separated and detected. The superior lot-to-lot reproducibility guarantees highly reliable results. BioPro IEX SF with its strong cation exchanger functionality is particularly ideal for analysing charge variants of monoclonal antibodies (mAbs) or other proteins. The strong anion exchanger BioPro IEX QF is the first choice for high-resolution analysis of oligonucleotides of different lengths as well as mAbs with lower pI.
The combination of the bioinert coated column hardware and the high efficiency stationary phases of YMC Accura BioPro IEX columns provide excellent peak shapes for sensitive compounds. They ensure high recovery from the very first injection and prevent carry-over. YMC Accura BioPro IEX columns are not only very inert, but are also available with smaller column IDs, making them ideal for use in native IEX-MS analysis.
More information online:
ilmt.co/PL/KYke and
ilmt.co/PL/34j1 62489pr@reply-direct.com
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