All Article articles – Page 5
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ArticleMAS-100 Libra®: the future of continuous cleanroom monitoring
Microbiological monitoring is essential for pharmaceutical facilities. As regulatory standards tighten, especially in cleanroom classes A and B, the need for reliable, continuous monitoring has grown. The MAS-100 Libra meets these demands by combining traditional settle plate methods with advanced automation, improving efficiency and accuracy.
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ArticleUnderstanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
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ArticleThe future of media hydration: balanced media in automated single-use platforms
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
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ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
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ArticleGuide to Outsourcing 2024
In this Guide to Outsourcing article, Jessica Rayser, Associate Director Product Management, Accugenix®, explores how outsourcing microbial identification can benefit technicians and facilitate the most accurate identification possible.
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ArticleEuropean Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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ArticleLife sciences response to 2024 Autumn Budget
Research and innovation is highlighted in the UK’s Autumn Budget as a priority ‘crucial national asset’ to aid long-term economic growth.
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ArticleDeveloping donanemab - balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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ArticleInnovating allergy drug delivery with a needle-free alternative
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
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ArticleAdvancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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ArticleCPHI Milan 2024: everything you need to know
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.
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ArticleFuture of oral small molecule drugs - addressing potential in multiple sclerosis
Advances in selectivity, safety, and patient convenience, oral small molecule drugs continue to be a key focus in drug development. Here, Dr Andreas Muehler and Daniel Vitt, PhD, the co-founders of Immunic Therapeutics, discuss the potential of Vidofludimus calcium as a breakthrough treatment for autoimmune diseases.
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ArticleQuality from the start: designing a scalable AAV production platform
This Feature Partnership discusses AAVs and how manufacturers can overcome the key development challenges and create a scalable AAV production platform.
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ArticlePatient insights into the decentralisation of clinical trials
While a trial is a part of pharma research, despite industry advancement, the patient experience is not often considered for innovation.
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ArticleHow ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
This feature partnership covers how pharma companies can ensure they are end-to-end compliant with Annex 1 for their primary packaging via a robust CCS.
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ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus explores environmental monitoring of compressed gas ports and best practice for minimising contamination risks.
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ArticleEuropean Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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ArticleEnzyme replacement therapy: improving outcomes in rare disease
In this article, Dr Alaa Hamed, Global Head of Medical Affairs for Rare Disease at Sanofi, shares why the company’s enzyme replacement therapy Xenpozyme® (olipudase alfa) has promise for the rare genetic disease acid sphingomyelinase deficiency (ASMD).
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ArticleAdvancing NOX inhibitors for treating fibrotic diseases and cancer
This article explores the benefit of NOX inhibitors for fibrotic diseases and cancers and highlights the potential of Calliditas Therapeutics’ drug setanaxib, including its application in wider related indications.
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ArticleMpox update - August 2024
This article discusses the impact of the recent mpox emergency following the outbreak of the virus in 2022, highlights the industry’s response, potential vaccine candidates and key recommendations for international management of the disease.