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23


Studying the Aggregation of Protein Drugs and Vaccines


Coriolis PharmaServices GmbH is using NanoSight’s LM-20 nanoparticle characterisation system to investigate the aggregation behaviour of protein drugs and vaccines. Coriolis is a contract research organisation for the formulation and analytics of pharmaceutical proteins and vaccines for their customers from national and international pharmaceutical companies. A special focus during formulation development is set on the characterisation of subvisible particles and aggregation. The main application requirement for the NanoSight system is to measure the number and the size distribution of aggregates in pharmaceutical protein formulations and of vaccines, e.g. virus-like particles. Protein aggregation is a major stability issue and can result in reduced biological activity and enhanced immunogenicity of the product. Therefore, it is important to analyse the aggregation behaviour of pharmaceutical proteins and develop methods and formulations that avoid aggregation already at the beginning of formulation development.


Coriolis uses a variety of instrumental techniques to quantify and size aggregates, depending on the size range of interest. Dynamic light scattering is ideal to analyse monodisperse systems, but once the aggregates start to form and grow, nanoparticle tracking analysis (NTA) from NanoSight gives a real distribution picture. For samples in the µm range, microflow imaging (MFI) and light obscuration are used. In contrast to DLS, NTA works well with polydisperse samples giving an estimation of the total concentration of particles and the possibility to distinguish different size populations. This is not possible by DLS due to the poor resolution. To achieve a comprehensive characterisation of nanoscale particulates in protein formulations, it is important to combine techniques that operate in that range. However, the ability of NTA to provide a real-time image of samples permits the analysis of potentially occurring difficulties during the measurement which is not possible using DLS.


Circle no. 78 Accurately and Efficiently Monitor the Performance of HbA1c Assays


The American Diabetes Association, International Diabetes Federation and European Association for the Study of Diabetes consider HbA1c a more reliable indicator of long-term diabetic control than blood glucose. In order to have confidence in the patient results reported good quality control is essential. A good control should be consistent over repeated analysis; have a good working stability and a long shelf life Randox can provide just this.


The new HbA1c control from Randox is made from 100% human whole blood and is designed to accurately and efficiently monitor the performance of HbA1c assays. Accurately assigned % HbA1c target values and ranges with corresponding Total Haemoglobin and HbA1c concentration values are provided for all major systems and methods including HPLC. The HbA1c controls are lyophilised providing enhanced shelf life and stability. An extended shelf life reduces the frequency of lot crossovers and allows users to sequester and use the same lot of control over a number of years significantly reducing reagent costs. A working stability of 28 days at 2-8oC minimises waste and saves money. To complement the HbA1c controls an HbA1c linearity set is also available designed to verify the linearity of HbA1c assays across the clinically important range. Four clinically significant levels are provided eliminating the requirement for very low and or very high patient samples normally used to assess linearity. Like the HbA1c controls the linearity set is suitable for use on all platforms and contains accurately assigned values for the most common analysers and methods.


Circle no. 79 ADVERTORIAL


Heathrow Scientific® Introduces True North® Cool Containers


New Disposable Staining Tray Set from Heathrow Scientific®


Heathrow Scientific is proud to announce a new Disposable Staining Slide Tray Set offering a clean and fresh working surface area every time. The tray is designed for staining, rinsing, and drying up to eight (8) slides on a single working tray. Both tray and lid are made of a rugged polypropylene and polyethylene blend, and provide an economical alternative to metal versions. Made for short-term convenience, the set features four (4) Base Trays and one (1) Lid for single usage or use over and over until a new one is needed.


Up to eight slides fit comfortably onto each base and the deep well holds liquid waste up to 38mL. With its compact size and recessed handles, the staining tray provides comfortable transport from work area to sink. According to Mic Jensen, Product Development Manager, “We wanted to make sure the tray was rigid for safe transport and also included two convenient pour spouts on opposing sides to make it easy to dispose of unwanted liquid waste.” The distinctive dark lid protects slides when used with light sensitive applications. A comfortable top grip makes it easy to remove the lid. Staining Tray sets are available now from Heathrow Scientific.


Circle no. 80 KEEP YOUR LAB AND BUDGET OPERATING SMOOTHLY


Heathrow Scientific is proud to announce a line of True North®


Cool Containers. Made of rigid single-moulded


polyurethane, Cool Containers provide the durability needed for chilling temperature sensitive samples. With excellent


insulation properties, they are ideal for ice, LN2, ice-salt slurries and more. The snug-fit lid features a comfortable recessed knob and has been meticulously designed to keep evaporation at a minimum. Plus, the lid conveniently stores underneath the bucket or pan since both base and lid are keyed to fit together.


According to Product Developer, Thiphachan Keobouvanh, “We wanted to make certain that function was a big consideration in the design.” This is evident by the tapered sides to make stacking and storage compact. Keobouvanh continued, “We ergonomically designed the handles to assist in safe transport of the bucket or pan from work area to the sink and added the handy pour spout to make draining melted ice, water and solutions easy.” All Cool Containers boast deep internal cavities with enough room to add one of your favourite Heathrow racks. Cool Containers are sold as eaches in four convenient sizes: 4L bucket, 1L pan, 4L pan and 9L pan. Each is finished in crystal-inspired colours for effortless colour coding. Cool Containers will be in stock from Heathrow Scientific the end of October.


Heathrow Scientific has experience in making products for safe storage in mechanical freezers or for use with liquid nitrogen with the Arctic Squares line of Freezer Racks and Polycarbonate Cryostorage Boxes. Other True North brand products from Heathrow Scientific include Chilling Jars that quickly freeze samples at -1°C per minute and Slide Boxes for ultra low temperature storage.


Circle no. 81


Won’t Put Your in a


Sea Star™ Spin


Budget


 Soft start and low speed setting for staining and de-staining of gels


 Sturdy platform for assay plates, open vessels, culture fl asks and more


 Ideal for long and/or overnight requirements  Instant speed adjustment from 20 to 300 rpm


 Powers 100 to 240 VAC, 50/60 Hz with universal adapter plug


Sea Star™ Orbital Shaker tracks timed runs, continuous usage and rpm settings for improved test procedure repeatability. Nonstop optical motor feedback provides instantaneous speed adjustment. Turn the speed knob for gentle agitation or vigorous orbital motion. Slow start motion decreases the risk of spills. Low rpm provides gentle shaking for molecular biology and immunology applications. Ideally priced and built-to-last.


Manufacturer of Quality Laboratory Products


www.heathrowscientifi c.com info@heathrowscientifi c.com


Circle no. 82


Spotlight


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