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Custom cryopreservation solutions for advanced cell therapies AMSBIO’s CELLBANKER®


freezing media is now customisable, seamlessly integrating into cell manufacturing processes with personalised


formulations, volumes, and packaging. With over 500 scientific publications citing the CELLBANKER range, it has proven to be a safe and reliable solution for storing cells and tissues, including GMP-grade, chemically defined formulations designed for clinical applications.


As cell and gene therapies gain widespread adoption, advancements in cell manufacturing and processing become crucial. AMSBIO recognises the need for high-quality equipment and reagents that seamlessly integrate into large-scale cell production processes. To address diverse cell therapies’ manufacturing needs, AMSBIO offers a consultation service to customise CELLBANKER in different packaging and formulations, optimising cell production efficiency.


Given the dynamic nature of cell manufacturing, where the limitations of standard CELLBANKER plastic bottles become evident, AMSBIO’s consultation service presents adaptable solutions. Ranging from flexible packaging alternatives to formulations optimised for various closed systems, AMSBIO ensures the fulfilment of the evolving requirements of large-scale cell therapy production.


From consultation to the development of non-GMP prototypes and large-scale GMP manufacturing adhering to pharmaceutical standards, AMSBIO


stands at the forefront of cryopreservation media expertise. The company delivers unparalleled, tailored storage solutions to meet the ever-evolving needs of cell therapy products in a large-scale production setting.


More information online: ilmt.co/PL/V2Jn 61805pr@reply-direct.com


Innovative pH measurement method for particle sizing


Fritsch has pioneered a ground-breaking method to measure the pH value of dispersion liquids directly within the measuring unit. The newly integrated pH sensor module in the dispersion bath is connected to the Laser Particle Sizer, enabling continuous pH monitoring during measurements and automatic data transfer to the software for documentation.


This patented approach proves significantly more effective in handling fluctuations compared to the zeta potential method. It offers substantial advantages, particularly in research and development contexts. The pH value holds broader significance, especially in nano- suspension measurements, providing valuable insights into how chemically inert materials react to varying environmental conditions. When measurement curves are unstable, the pH value aids in stabilisation and interpretation. Moreover, Fritsch’s newly introduced patented pH measurement method allows for precise observation, facilitating the detection of agglomeration or aggregation.


FRITSCH Particle Sizers offer state-of-the-art particle sizing solutions, catering to both production and quality control, as well as research and development applications, and manufacturing process control. The Fritsch A-22 NeXT Nano, a Laser Particle Sizer, excels in accuracy and sensitivity, covering a wide measuring range from 0.01 to 3800 μm. Additionally, a Micro version offers an economical alternative with a measuring range from 0.5 to 1500 μm. Both models feature a single laser and numerous patented features to ensure maximum durability and minimal maintenance.


These instruments are designed for easy installation through plug-and-play functionality, tool-free cleaning with simple steps, and come with high-performance software, meeting 21 CFR Part 11 requirements. Fritsch Laser Particle Sizers ANALYSETTE 22 NeXT adhere to a smart, modular concept, allowing customers to purchase only the necessary components and scale their sizing capabilities as needed.


Contact Fritsch for videos, whitepapers, sizing protocols, and other resources on laser particle sizing. More information online: ilmt.co/PL/VeG3 and ilmt.co/PL/8Nev


61297pr@reply-direct.com


New desiccant with colour-changing indicator Elemental Microanalysis, a leading global supplier to the elemental analysis market, is pleased to announce brand new drying agent, DrysorberTM


with colour changing indicators.


Elemental’s in-house R&D team developed every aspect of Drysorber to be easy to use – from tube fill to moisture indication. Drysorber is composed of several sizes of drying agent spheres and an indicator. The larger spheres of drying agent will dissolve as they are spent. Elemental’s Drysorber also contains an indicator which will undergo a change from pale blue to pink as the larger spheres absorb water. The colour indicator offers easy recognition of when the drying agent needs replacing - as well as confirmation that any opened, stored product is still viable for use.


“The obsolescence of Sicapent to the elemental analysis market offered an opportunity for Elemental Microanalysis to develop a drying agent in-house for the needs of our customers with Elementar analysers,” noted Paul Stevens, Director of Operations. “Our R&D team, helmed by David Castle, developed a desiccant that is both uniquely non-clumping and offers distinct visual clue on replacement status.”


Drysorber is suitable for use in Elementar® analysers where Sicapent® was previously recommended, in instrument modes for C, H, N, and O detection. Supplied in


a 230 g bottle, this granular, free-flowing product ensures easy filling of drying tubes. Additionally, Drysorber is not considered dangerous goods for shipping at the 230g size. More information online: ilmt.co/PL/X1w8


61258pr@reply-direct.com


New ASTM standard ensures reliable HPC testing IDEXX, the global expert in water microbiology, has announced that its EasyDisc®


(B1327)


PCA, YEA and R2A tests, for the for the detection of heterotrophic plate counts


(HPC) in water, have been published by ASTM International as the ‘ASTM D8516-23: Standard Test Method for Quantification of Culturable Waterborne Bacteria Using a Defined Culture Medium Coated Plate’. ASTM International is an international organisation that develops and publishes standards applicable to a wide variety of industries. There are over 12,500 global ASTM standards, developed and reviewed by over 30,000 technical experts from more than 140 participating countries.


IDEXX launched EasyDisc in 2021, which is a simple solution for HPC testing, needing no agar preparation, and requiring less than one minute of hands-on time to process a sample. Post-incubation, blue colonies reduce the ambiguity of results, and colony counting is made easier by the integrated gridlines in the EasyDisc plate. With a 12-month shelf life, EasyDisc reduces the need for repetitive quality control checks and ensures that tests are ready when needed.


EasyDisc formulations cover all categories of HPC testing: PCA and YEA, which correlate with the pour plate method using plate count agar and yeast extract agar respectively, for the testing of drinking and source water; and R2A that is comparable to the pour plate method using Reasoner’s 2 agar for the testing of medical and/or pharmaceutical waters. In 2022, IDEXX expanded the EasyDisc platform with the DEV test, designed to correlate with the German Drinking Water Directive (TrinkwV), §15(1c).


This publication as a standard follows EasyDisc YEA test being validated and certified by the French standards organisation, AFNOR, with ‘NF Validation’ for the enumeration of cultural micro-organisms in water for human consumption (drinking water) under reference IDX 33/09-03/22.


EasyDisc complements other innovative water testing methods from IDEXX, which include liquid culture methods for the rapid enumeration of E. coli and coliform bacteria, as well as detection methods for enterococci, Pseudomonas aeruginosa and Legionella pneumophila. More recently, IDEXX has introduced Tecta®


for fully automated water microbiology testing. More information online: ilmt.co/PL/Rebk and ilmt.co/PL/qjE4 61335pr@reply-direct.com


INTERNATIONAL LABMATE - FEBRUARY 2024


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