20 Combining Freeze Drying and High Pressure Homogenisation for Ultra-Fine Nanocrystal Production


In recent years, nanomedicine has proven to be key in overcoming many of the challenges associated with poorly water-soluble drugs. Decreasing the size of drug particles can increase bioavailability and solubility, as a result of the increased API surface area.


Due to increased bioavailability, a lower amount of API is required, which in turn leads to a more cost-efficient product, with less risks and side effects for the patient.


High pressure homogenisation has long been the favoured method of particle size reduction and is often considered as a first-generation approach. Recently, second-generation approaches have been introduced and these involve a combination of technologies (SmartCrystal processes). One of which is known as the H96 process -the combination of freeze drying, followed by high pressure homogenisation.


The aim is to modify the starting material in such a way, that it can be better broken down by high pressure homogenisation.


Benefits of combinative technology include: faster production of the nanocrystal, by reducing the number of required homogenisation cycles/ passes; higher physical stability; smaller achievable particle size; improved in vivo performance. The H96 process involves initial freeze drying of an organic solution of the poorly water-soluble drug.


Another benefit of the H96 approach is a reduction in the required number of homogenisation cycles/passes to achieve the desired particle size and/or size distribution.


At pilot and production scale, this could bring about significant cost-savings, as a result of reduced processing and labour time, reduced wear rates and machine downtime, all of which improve the overall commercial viability of the process/project.


Biopharma Group supply high pressure homogenisers across the UK & Ireland, as well as the market-leading SP Scientific freeze dryers - all fully supported by their Technical Service Team


Biopharma Group’s experience has been established with more than 3000 projects developed for APIs, biopharmaceuticals, therapeutic delivery systems, PCR reagents, whole organisms, vaccines, blood components, food and nutraceuticals ensuring success in many industrial processes, globally. More information online: ilmt.co/PL/2XPL


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Ergonomic Pipettes for Precision Liquid Handling


IKA PETTE unites everything lab technicians can expect for reliable metering in a single instrument. All models are fully autoclavable and can be easily sterilised. This ensures accuracy, precision and safety when metering. The large mechanical volume display is also easy to read as you perform the metering. The lightweight pipettes are particularly pleasant to hold thanks to three interchangeable ergonomic grips. The geometry of the receptacle is designed so that it is suitable for all commercially-available tips.


IKA PETTE fix and vario are also shock-resistant, UV and chemical resistant. Calibration and maintenance is user-friendly and can be done yourself or with the help of IKA Service.


More information online: ilmt.co/PL/n519 54416pr@reply-direct.com


Liquid Nitrogen Auto-fill Pump for Efficient Cooling and Filling of Low Pressure Temperature Controlled Applications Norhof manufactures LN2


auto-fill systems. When LN2 is required,


a small overpressure (100 mBar) is generated by a small heater element in the LN2


cooling application. inside the Dewar. Liquid flows smoothly out


of the system similar to water from a tap, without spilling, noise and vibrations, ensuring efficient and safe filling and level control in your LN2


Norhof’s flagship system is the #900 series, which is fully programmable with several control options, based on one or two sensors in level or temperature.


Applications for the Norhof #900 series LN2 automatic LN2 automatic LN2


auto-fill include:


filling system for FTIR; automatic filling system for DSC; filling system for TMA; LN2


Cold Trap filling; LN2 heat


exchangers PID temperature control; Computer Controlled Freezing; Gas Chromatography; Temperature stages in microscopes.


More information online: ilmt.co/PL/oDLO 54071pr@reply-direct.com


New Quantitative COVID-19 Test Kit for Precision Antibody Detection Introduced


The Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test From EKF iDiagnostics is one of first to detect both the presence and precise levels of COVID-19 neutralising antibodies. Detecting specific quantities of human IgG antibodies to the SARS-CoV-2 virus enables superior understanding in many COVID -19 areas.


With FDA Emergency Use Authorization (EUA), this high performance CE marked quantitative COVID-SeroKlir kit has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two SARS-CoV-2 virus antigens, the full-length spike protein and its receptor-binding domain (RBD). This confirmed accuracy means false positives and false negatives are minimised.


COVID-seroKlir’s accuracy is ensured by a two-step enzyme-linked immunosorbent assay (ELISA). Using standard methods and equipment, the kit is easily operated without need for scaled equipment or special environments. Each kit contains components to test 630 patient samples.


COVID-SeroKlir has been validated on a highly diverse cohort of more than 75,000 patients, including over 30,000 who were diagnosed with COVID-19; more than any other COVID-19 test during studies at the Icahn School of Medicine at Mount Sinai Health System in New York. The test has also been independently verified by peer reviewed journals, including Nature and Science as well as the US National Institutes of Health (NIH).


The study also demonstrated that over 90% of infected individuals with mild-to-moderate COVID-19 experience robust IgG antibody responses against the viral spike protein. In addition, these COVID-19 neutralising antibody levels were confirmed to be relatively stable during the first five months after infection


Explaining the value of knowing the precise levels of SARS-CoV-2 IgG antibodies, Julian Baines, CEO of EKF, said, “Quantitative IgG antibody testing can provide important support for determining public health strategies, informing healthcare decision making, and verifying the effectiveness of vaccines as they become available. It is also an essential component of a general health check to determine past COVID-19 infections. This is because COVID-19 has been linked with an increased risk of potentially life-threatening complications, including lung, kidney, and cardiovascular disease.”


EKF holds exclusive rights to market and distribute the Kantaro COVID-SeroKlir kit in the UK and Germany, and non-exclusive rights in the rest of Europe. More information online: ilmt.co/PL/XRV0


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LABMATE UK & IRELAND - MARCH 2021


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