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European Biopharmaceutical Review
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'Robot' is a Czech word meaning worker, from the play RUR: Rossums' Universal Robots by the Bohemian writer Karel Capek. The robot has since become an inspiration for science fiction writers and for engineers. Of course the science fiction vision of a robot is a mechanical man, but the reality we see in industry is simply a robotic arm. This is a versatile programmable manipulator, an integration of mechanics, electronics and software, designed interdependently to produce the mechanical equivalent of the computer - an undedicated machine unable to do anything until we program it.
In the pharmaceutical lab it is even less than that definition; the term 'robot' being applied to programmable liquid handlers. Drug development requires the screening of hundreds or thousands of samples and it is in this field that the robot arm is a vital tool. Such an automated screening system is called a 'high-throughput screening' (HTS) system.
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News and Press Releases |
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Sphere Fluidics introduces latest version of Cyto-Mine Studio Software Suite
Cambridge, UK, 27 August 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, today introduced an updated version of its Cyto-Mine® Studio Software Suite, a collection of software controlling operation of its Cyto-Mine Single Cell Analysis System, data acquisition and follow-up analysis. The latest software version includes new functionality to further enhance users’ workflows in biologics discovery and cell line development.
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events |
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2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
2020, in Amsterdam, The Netherlands.
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