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Quality 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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Biopharma
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European manufacturing facility to strengthen gene therapy supply
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
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Patient 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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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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Application note: Single temperature analysis for environmental monitoring samples
This application note explores how to determine the feasibility and the impact of the single temperature for environmental monitoring microorganisms.
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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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Optimising wet granulation manufacturing with advanced technologies
The approach proposed in the paper suggests how artificial intelligence (AI) and machine learning (ML) could enhance process efficiency and product quality during complex manufacturing.
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First-in-class therapy approved for schizophrenia
The “landmark” approval represents the first new class of medicine in several decades for treating schizophrenia.
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WHO guidance aims to strengthen clinical trial ecosystem
The new recommendations are applicable to clinical trials in countries of all income levels and seek to make trials more effective and supportive for a diverse range of participants.
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PharmaLab Congress 2024 – what’s new for the third year in Düsseldorf/Neuss
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
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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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New collaboration to boost access to innovative microbiome therapies
The new agreement, focused on improving regulation and drug development within the microbiome therapeutic sector, will harness cross-sector cooperation to ensure these medicines become available to more patients.
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Sepsis: addressing unmet needs for a global priority
Limited funding and a lack of drugs targeting the root cause of sepsis are some of the current obstacles when addressing the disease burden, GlobalData says.
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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.
