Chromatography 19 Effective Virus Particle Analysis Using Dynamic Light Scattering


Testa Analytical Solutions eK reports that Dynamic Light Scattering (DLS) can be used as an effective analytical technique for analysing virus particles in solution. A new application report examines four fi sh viruses incubated under laboratory culture conditions that have the potential to wreak signifi cant economic damage to both recreational and commercially important fi sh populations.


Traditional visual methods of observing virus particles in solution give a snapshot of only a very small and potentially unrepresentative sampling volume. By comparison, the technique of particle analysis using dynamic light scattering yields an ensemble average of particles present in these solutions. Data presented in the report is from DLS measurements made on a NanoBrook ZetaPALS instrument equipped with a BI-MAS accessory to provide particle sizing capability.


The authors discuss how analysing virus particles incubated in the laboratory present a challenge, as they must be grown within cells in a media containing albumin and other small proteins, such as those present in Fetal Bovine Serum (FBS) solution. When virus particles are released from the cells, the cell fragments are large and can be separated by centrifugation, but the smaller proteins of the media cannot be removed. Careful selection of the distribution parameters from a dynamic light scattering experiment allows the size distributions of virus particles to be clearly observed in the presence of much smaller proteins that constitute the media.


The results presented in the applications report clearly show the presence of virus particles with the expected average dimensions when observed by an intensity weighted distribution. However the absence of these particles in the number distribution shows the virus particles are present in relatively small numbers compared to the proteins and other small molecules in cell growth media.


The Nanobrook ZetaPALS from Testa Analytical provides a platform for zeta potential determination of nanoparticles and colloids in water with salt concentrations less than 75 millimolar ionic strength. The instrument is designed to eliminate the shortcomings inherent in other zeta potential instruments.


For a copy of the application report please visit ilmt.co/PL/Vkkm More information online: ilmt.co/PL/a22W


53035pr@reply-direct.com


Total Nitrosamine Testing for Pharmaceuticals Introduced


As the European Medicines Agency (EMA) risk assessment deadline takes hold, Ellutia’s total nitrosamines pre-screening solution offers the pharmaceutical industry a simple, accurate and reliable test. This delivers a clear pass/fail result for apparent total nitrosamine content (ATNC) in minutes, allowing samples to be immediately cleared for processing or sent for further testing.


From April 2020, all marketing authorisation holders of medicines containing chemically synthesised active pharmaceutical ingredients (APIs) must conduct a risk assessment to evaluate the possibility of nitrosamines being present.


Any sample showing an ATNC below the World Health


Organisation (WHO)’s specifi ed interim limit cannot possibly contain any one nitrosamine above the total level, and so can be deemed safe.


The Ellutia ATNC test is based on the 800 Series Thermal Energy Analyser (TEA) interfaced to a unique chemical stripping system. It allows pharmaceutical manufacturers to meet the requirements of the EMA risk assessment without needing to outsource testing of raw materials or of product at different stages of manufacturing.


Andrew James, Marketing Director at Ellutia, said: “Measuring apparent total nitrosamine content (ATNC) provides a benchmark of the nitrosamine volume in a product. Rather than embark on a lengthy analytical process to deliver detailed and speciated results in the fi rst instance, the ATNC method screens only for the total nitrosamine content, both volatile and non- volatile compounds, and returns an analysis with a single clear peak. If this peak falls under the interim allowable daily intakes set by the World Health Organisation (WHO) for specifi c species of nitrosamines, the total nitrosamine content is permitted and the product is safe.


“In contrast, any sample found to contain an ATNC outside the safe level can be red fl agged and sent for further analysis by a TEA interfaced to a GC or HPLC to individually identify the species and quantify the presence of nitrosamines such as NDMA.


“The risk assessment requirement from the European medicines agency means that pharmaceutical manufacturers need to take a serious look at potential nitrosamine contamination in their product lines. In America, too, the US Food and Drug Administration (FDA) has also already acted to call in various drugs known as ARBs for testing.”


The TEA has become the industry go-to for nitrosamine testing in GMP manufacturing environments such as food safety and materials testing. Coupled with Ellutia’s chemical stripping system, the instrument is seeing take up in pharmaceuticals testing.


More information online: ilmt.co/PL/Lpm3 and ilmt.co/PL/xQp6 51713pr@reply-direct.com


RSA™ Autosampler Vials for Not All Vials Are Created Equally & Only RSA™


better chromatography data. Vials:


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New Pre-packed Columns for Fast Method Development Introduced


Tosoh Bioscience GmbH, a provider of chromatographic solutions for the separation and purifi cation of biomolecules, announced today the introduction of SkillPak 1 mL and 5 mL pre-packed columns. These process development columns are designed for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.


Pre-packed with TOYOPEARL® , TSKgel® or Ca++Pure-HA® process


chromatography media, SkillPak 1 mL and 5 mL columns deliver high performance and offer scalability and convenience - giving customers greater fl exibility for use of process media from Tosoh. These columns are ready to use upon receipt and show excellent physical strength and ideal fl ow characteristics for industrial downstream processing.


SkillPak 1 mL and 5 mL pre-packed columns are available with short delivery times in affi nity, anion and cation exchange, hydrophobic interaction and size exclusion chromatographic modes. Optimal performance is guaranteed with the columns and they can be operated directly with commonly used low or medium pressure liquid chromatography systems.


SkillPak 1 mL and 5 mL pre-packed columns are now available for sale in Europe, Africa and the Middle East from Tosoh Bioscience GmbH.


More information online: ilmt.co/PL/Lpx5 52332pr@reply-direct.com


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