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| home > ebr > Spring 2016 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
EBR’s Editor Deborah O’Neil ponders the impact of the digital age on pharma and the improved data handling this facilitates, along with other focus features in this edition.
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Wearable Technology
Technically Speaking
Despite the growing popularity of health technologies, much uncertainty still surrounds digital healthcare and the exact definition of this ever-expanding field, say CMS Life Sciences Group’s Sarah Hanson and Laura Lucy.
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Smart Healthcare
Intelligent Design
The Internet of Things is the latest wave of technology sweeping the healthcare landscape, observes Jonathan Wilkins at European Automation – who assesses some of the radical and potentially life-saving technologies it could bring.
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Automation Advances
Rise of the Machines
Recent advances in cognitive computing could drastically shake up the industry, states IBM's Institute for Business Value’s Heather Fraser, enabling fast and more accurate decisionmaking by healthcare professionals to enhance patient care.
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Biologics Characterisation
Compare the Market
The characterisation of biological products has become ever-more reliant on advanced technology, states Fredrik Sundberg at GE Healthcare. He explains why surface plasmon resonance and sensorgram comparison offer vast benefits.
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Molecular Analysis
Measuring Up Nicely
A “fast, absolute and inherently simple method”, the emerging Taylor dispersion analysis system offers unique benefits compared to other long-established techniques, say Dr Steve Carrington and Dr Lisa Newey-Keane at Malvern Instruments.
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Microscopy Advances
Culture Shift
The modern cell culture microscope is continuing to assist researchers improve workflow efficiency and make new discoveries. Olympus Europa’s Joachim Kirschner highlights where he believes light microscopy can take science in the near future.
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Supply Chain Agility
Quick on the Draw
Agility – within all stages of pharma manufacturing – is key to achieving success in company goals, believes Mark Evenepoel at AMPLEXOR Life Sciences.
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Sample Preservation
From Collection to Destruction
All biological samples, whether successful or not, could prove valuable in future biomarker studies – which is why extreme care must be taken when handling and transporting these highly delicate products, explains Eric Hayashi at LabConnect.
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Q&A: Rare Cancer Treatments
Making Waves
As recent reports reveal that acute myeloid leukaemia – a rare cancer form – is expected to rise with an ageing population, Actinium Pharmaceuticals’ Dragan Cicic describes how a promising new radio-immunotherapy treatment could boost patient survival rates.
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Immunotherapy Advances
Armed Against Cancer
CAR-T cell therapy – which involves engineering patients’ own immune cells to detect and attack tumours – is giving rise to a new generation of groundbreaking cancer treatments, including NKG2D, which could wipe out up to 80% of cancers, reports Christian Homsy at Celyad.
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Oncology Research
Modify This
Alfred Hansel and Martina Schmitz at oncgnostics GmbH explain the growing popularity of epigenetic modifications in cancer treatment.
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Medical Affairs
Surveying Change
Dr Fabio Gambini, Paolo Morelli and Mary Wieder at PM Clinical talks about the relatively new Medical Sciences Liaison role, and how plans to outsource this vital function could impact on the industry.
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In Brief
Eye of the Storm
Emile Bellott comments on the growing prominence of biosimilars, which are currently gaining visibility at the highest government levels, and some of the challenges this presents.
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Protein Structure
Multiple Choices
Before any biologic drug can be approved, the first crucial step is to obtain a full and accurate profile of the protein molecule – which can only be achieved by using a combination of techniques, states Iñigo Rodriguez-Mendieta at SGS.
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News and Press Releases |
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Novo Nordisk Pharmatech A/S enters a distribution agreement with Signet Chemical Corporation Pvt. Ltd. for cGMP Quaternary Ammonium Compounds for pharmaceutical and medical device applications
Novo Nordisk Pharmatech A/S has entered into an agreement with Signet
Chemical Corporation Pvt. Ltd. for the distribution of their
pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to
the healthcare industry in India, Bangladesh and Sri Lanka.
More info >> |
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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.
More info >> |
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Industry Events |
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PDA Universe of Pre-Filled Syringes and Injection Devices
8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL
At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments,
regulatory considerations, challenges, and industry trends and best practices.
This is a must-attend event for all industry professionals involved in the
development, manufacturing, testing, or marketing of pre-filled syringes and
injection devices.
More info >> |
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