All Raw materials and supply chain (bioprocess) articles – Page 4
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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.
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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.
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NewsGenmab appoints new EVP and Chief Technology Officer
The new member of Genmab’s Executive Committee brings over 30 years of international biopharmaceutical experience to the role.
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WhitepaperScience of scale for spray-dried intermediates
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
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WhitepaperSynthesis and Route Design to Tackle API Complexity
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
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ReportPharma Horizons: Formulation
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
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WhitepaperApplication note: Highly efficient method development using LC-MS for automated peak tracking
Peak tracking in liquid chromatography (LC) method development can be challenging due to retention variations and co-elution. LabSolutions MD software with LCMS-2050 SQ-MS simplifies peak identification and automates method and sequence creation, enabling efficient development of reliable separation methods.
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WhitepaperApplication note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
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NewsJ&J commits five-year investment in Italian medicine manufacturing
Currently, the Latina site exports 97 percent of the medicine it produces, according to Johnson & Johnson Innovative Medicine.
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NewsEFPIA sets out targets for pharma environmental sustainability
To drive environmental sustainability in pharma, EFPIA strives “to go beyond compliance on the targets set within the various EU legislative requirements as part of the EU Green Deal initiatives under the Zero Pollution, Circular Economy and Climate Action plans”.