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| home > ebr > Spring 2018 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
EBR Editor Dr Deborah O’Neil looks at the potential of cannabis use in healthcare, relating it to topics discussed in this edition.
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Future Migraine Treatment
Getting Ahead
Recent advancements in biopharmaceuticals in the area of migraine studies have the potential to bring relief to many individuals. Professor Dr Uwe Reuter at Charité Universitätsmedizin explains how.
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Immunogenicity and the Development of Biopharmaceuticals
Sudden Impact
Dr Gary Bembridge and Dr Karen Hills at Abzena comment on the approaches that can be taken in the pre-clinical stages to reduce the effects of immunogenicity on patient experience and product success.
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Technologies for Targeting the Cell Surfaceome
Scratching the Surface
Dr Maria Pavlou and Dr Paul Helbling at Dualsystems Biotech suggest that developing methodologies to study the surfaceome is crucial to cellular differentiation advancement, resulting in the creation of new treatments.
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The Potential of Bacterial Lysates
From Pharma to Beauty
Bacterial lysates can be used in many applications, especially disease protection, due to their ability to act as an immune stimulant. Dr Christian Sanchez and Maxence de Villemeur at Lallemand Pharma analyse further.
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Regulatory Challenges
Rules for Success
Dr William Bridges at Regulatory Affairs Professionals Society believes that regulatory aspects can propel an organisation towards success by enforcing policies, compliance, and good practices.
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In Brief
Precision Healthcare
EBR’s Industry Advisor, Emile Bellott, surveys the potential ramifications of Amazon’s recently announced healthcare services, which aims to be an affordable solution for consumers.
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Q&A: Albumin in Cell Culture
Therapy at Work
EBR asked Dr Daniel Shelly at Albumedix about cell therapy, looking specifically at the use of albumin in cell culture and current treatments, as well as the challenges that have to be overcome.
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Animal Component-Free Media Formulations
Blood-Free Matters
Dr Randall Alfano at InVitria Product Development describes the use of fetal bovine serum in the advancement of in vitro biology, but suggests that a serum-free media formulation could enhance safety and reproducibility.
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Customised Viral Engineering
Proactive Progress
Customised viral engineering can create safe and effective adeno-associated virus gene delivery, reveal Tatjana Buchholz at PlasmidFactory, Dr Carl J Christel at Sirion Biotech, and Dr Hüseyin Besir at PROGEN Biotechnik.
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Capturing Protein-Defining Information
Redefining Proteomics
Mass spectrometry can find the proteins that make a sample, but Dr Christian Loch at AVMBioMed highlights the extract-based functional assay technique.
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Personalised Medicine
At a Glance
Is society ready for personalised medicines and its ethical implications? Guenther Proll at Biametrics has the answer and examines the progress of its sequencing.
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Precision Medicine
Beyond the Genome
Dr Jason Mellad at Cambridge Epigenetix states that collaboration is key to realising the potential of epigenetic research, and successive innovations and applications can aid the industry’s understanding of this.
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Biomarkers in Oncology
Tomorrow’s Treatments
Tarquin Edwards at Peckwater PR claims that personalising cancer care and using biomarkers and personalised medicine in oncology is being supported by Big Pharma, thus transforming cancer treatments.
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Biobanks and Strategic Processes
Data Swap
Colin Thurston at Brooks Life Sciences recommends adopting three key biobank technology solutions to make research more stratified and effective, thereby aiding researchers.
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News and Press Releases |
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Nemera acquires Insight Product Development to strengthen its capabilities
“Every day at Nemera, we work to improve the lives of millions of patients worldwide by designing, developing and manufacturing innovative drug delivery devices. Our vision as a team is to become the most patient-centric drug delivery device company in the industry. We partner closely with our customers to deliver innovative and high quality devices, to ensure that patients will receive the best product and service possible” Marc Hämel, CEO
More info >> |
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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BioTrinity 2020
28-29 April 2020, Etc Venues, London
BioTrinity is a long-running and highly regarded two day life sciences conference that takes place in Central London from 28-29 April. BioTrinity focuses on partnering, investment and collaboration and aims to inspire growth and create opportunities for all who attend. The core delegate mix includes early-stage and emerging biotech, medtech and digital health companies, big pharma executives and life sciences investors.
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