All Article articles – Page 15
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ArticleILAP: Improving access to innovative oncology treatments
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
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ArticleDeveloping novel therapies for NASH
In this exclusive interview, Dr Hank Mansbach, Chief Medical Officer of 89bio discusses clinical development of FGF21 therapy to treat fatty liver disease.
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Articleebook: Nanoparticle formulations: overcoming dissolution challenges
This ebook explores the potential of nanoparticle formulations for drug delivery, as well techniques to predict in vivo bioavailability of these dosage forms.
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ArticleParallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
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ArticleHandling HPAPIs safely – what does it take?
Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
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ArticleLeading in Pharma: a woman’s pathway
Here, to mark International Women’s Day, Dr Ekaterina Malievskaia from COMPASS Pathways reveals her path to working in mental health and the pharma industry.
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ArticleLearning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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ArticlePrioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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ArticleComputed tomography for in-depth investigation of freeze-dried products
In this article, Teresa Siegert and Henning Gieseler, discuss the benefits of applying computed tomography in the production of freeze-dried pharmaceutical products, as well as the hurdles that must be navigated to realise its potential.
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ArticleNew workflow for the analysis of mRNA therapeutics
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
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ArticleNITROSAMINES: Where now?
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
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ArticleOvercoming barriers to capturing data in a laboratory
A key issue faced in pharmaceutical laboratories is the integration and standardisation of data from the array of instruments. Here, Samantha Kanza from the University of Southampton outlines some challenges with using laboratory information management systems or other digital tools. How might these be overcome?
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ArticleTaking advantage of protein charge properties for challenging separations
In this article, Mareia Frost, Scientific Leader at Abzena, explores how understanding the characteristics of protein‑based drugs, and applying the right techniques, means even the most complex biologics can be effectively separated from potentially-harmful impurities.
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ArticleUPC opt-out – a strategic balancing act for pharma
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail ...
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ArticleChallenges in pharmaceutical microbiology: looking to the future
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
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ArticleShining a light on Raman for microbiological analysis
The detection and identification of bacteria is essential for biopharmaceutical production, the assessment of new antimicrobials and assessing contamination control measures. Developing methods for complex environments is challenging due to interference from the various molecules present. Here, pharmaceutical microbiologist and contamination control expert Dr Tim Sandle explains how Raman spectroscopy ...
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ArticleAccelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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ArticleMoving towards oral delivery of biologics
In this article, EPR’s Caroline Peachey speaks to Talat Imran, CEO of Rani Therapeutics, about progress towards oral delivery of biologics using robotic capsules.
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ArticleUsing alkali-metal cation recognition of α-cyclodextrin to detect lithium ions by MALDI-TOF
Here, Ahmad Amini and Johan Carlsson from the Swedish Medical Products Agency discuss the use of matrix‑assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF MS) for identification of lithium in pharmaceutical preparations.
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Optimising fermentation with process analytical technology
This interview with Dr Marie Izac, Vaccine Drug Substance Unit Head at Sanofi Pasteur, elaborates on the use of process analytical technology – and specifically mass spectrometry – for continuous respiratory gas analysis.