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How 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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Manufacturing
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Environmental 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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European 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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Microbial contamination detection with rapid spectroscopy
The detection method was designed for continuous culture monitoring of cell therapy products and required minimal sample preparation, research showed.
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Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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Lilly $1.8 billion investment to bolster Irish manufacturing
The expansion is planned to support production of Eli Lilly and Company’s medicines for diabetes, obesity and Alzheimer's and both sites will harness advanced technology and sustainability capabilities.
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New WHO guidance to support manufacturers to reduce AMR risk
The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.
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An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
4 September 2024 | By Rapid Micro Biosystems
Watch on demand to learn how a new single medium, Rapid Sterility Medium (RSM), performs as well as or better for the growth promotion of test microorganisms compared to compendial sterility test media.
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Improving upstream fermentation with end-to-end automation
The automated system “significantly improved process control”, resulting in greater productivity of a small-molecule drug substance.
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Mpox 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.
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Innovative pharma-government partnership to enhance UK clinical trials
The first-of-a-kind investment supports the UK government’s objectives to boost clinical trials, improve patient access to novel treatments and increase competitiveness in life sciences.
whitepaper
eBook: Successfully navigating complex and evolving regulatory environment for combination products
With complex processes and stringent regulatory requirements, the path to developing a combination product can be uncertain and challenging
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AstraZeneca investment to increase biologic capacity in Sweden
The planned expansion is set to strengthen AstraZeneca’s capability to manufacture biologic medicines for patients globally.
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Are we set for the revised EU GMP Annex 1?
23 August 2024 | By
This blog is a summary of the key changes of relevance to primary packaging components
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Enhancing cell proliferation in bioproduction with non-invasive technology
The method has potential in both biomanufacturing and production of autologous cell therapies, the research suggests.
