All Raw materials and supply chain (bioprocess) articles – Page 4
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NewsNew EU guidance seeks to address radiopharmaceutical supply chain vulnerabilities
The recommendations are issued amid increasing pressure on the complex supply chain for radiopharmaceuticals, medicines which are used to treat conditions such as cancer.
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ArticleNavigating the regulatory challenge of PFAS for pharmaceutical manufacturers
Courtney Soulsby, Sector Development Director, Healthcare at the British Standards Institute, reveals how the industry can prepare for PFAS regulations now to get ahead of the curve.
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ArticleEuropean Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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NewsVulnerable medicine list to aid US medicine supply resilience
The analysis from the US Pharmacopeia (USP) provides a mitigation strategy for manufacturers and other stakeholders to improve reliability of medicines amidst supply chain challenges.
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ArticleHow could tariffs impact the pharmaceutical industry?
Proposed US tariffs on pharmaceutical imports could disrupt global supply chains, drive up production costs, and exacerbate drug shortages. How will the industry respond?
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NewsStabilising Europe’s generic medicine supply
Ahead of the Critical Medicines Act anticipated in 2025, Teva’s report offers policy recommendations to mitigate the economic pressures risking generic medicine availability in Europe.
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NewsClimate crisis and technological innovation shaping pharmaceutical water market
As a significant water consumer to enable production of high-quality medicines, this demand brings both challenges and opportunities for the pharmaceutical industry up to 2033, research suggests.
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NewsEU Urban Wastewater Treatment Directive may compromise EU medicine availability
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
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NewsAstraZeneca cancels £450m Liverpool vaccine facility expansion
Under growing global competition, this development highlights potential challenges for the UK to uphold large-scale pharmaceutical investments.
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NewsNICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
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NewsUK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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ArticleBiosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
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WebinarHow a well-orchestrated digital ecosystem drives laboratory efficiency and innovations
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
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WhitepaperNSF’s quality management maturity (QMM) assessment model
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
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WhitepaperRegulatory Authority Inspection Comparison
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
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NewsAI and automation to drive “substantial progress” in pharmaceutical analytical testing
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
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WhitepaperWhitepaper: Optimise organisational culture & quality maturity
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
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NewsEMA publishes EU strategy to 2028
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
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NewsEuropean 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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NewsNew 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.