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EDQM remote inspections to become permanent part of inspection scheme
The EDQM will include Real-Time Remote Inspections (RTEMIS) as an integral part of its system for the supervision of manufacturers of active substances from 2022.
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Active Pharmaceutical Ingredient (API)
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What to expect at the UK’s flagship event for Making Pharmaceuticals
1 March 2022 | By
Serious about Making Pharmaceuticals? Attend the UK’s largest event dedicated to supporting the future of the pharmaceutical product life-cycle.
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Pharmaceutical analysis with portable spectrometers
Richard Crocombe of Crocombe Spectroscopic Consulting surveys the use of portable spectrometers in pharmaceutical manufacturing, with an emphasis on vibrational spectroscopy. Ideal and typical features of portable spectrometers are reviewed, alongside explanation of why device characteristics and sample presentation are critical to obtaining meaningful results.
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Novel excipients for solubility enhancement
Lubrizol Life Science Health colleagues Nick DiFranco, Global Market Segment Manager for Oral Treatments, and Joey Glassco, Senior Global Market Manager for Parenteral Drug Delivery, explore the use of amorphous solid dispersions and polymeric micelles for solubility enhancement.
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Key challenges for bio/pharmaceutical manufacturing 2022
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
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New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
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US healthcare groups publish drug supply chain recommendations
Healthcare groups including the US Pharmacopeia and American Medical Association release advice for policymakers on addressing challenges in the US supply chain.
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Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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What to consider when formulating bacteriophages
In this article, Dr Michael Koeris, Associate Professor, Bioprocessing at Keck Graduate Institute, and Carolina Moraes de Souza, Keck MEng graduate, now Process Development Senior Associate at Amgen, discuss the key formulation considerations for bacteriophages, a potential solution to antimicrobial resistance, and why process development should be an early consideration.
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Machine vision allows real-time monitoring and control of low concentration APIs
Machine vision-based concentration determination enabled the accurate real-time monitoring and control of continuous powder blending.
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Formulation development of vitamin C-based effervescent blend suitable for direct compression
This article presents the findings from a study to establish optimum formulation parameters for effective effervescent vitamin C tablet production.
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Using co-processed excipient reduces PAT measurement errors, finds study
New research shows co-processed excipient is superior to non-co-processed when using near infrared (NIR) process analytical technology (PAT) to monitor direct compression tableting.
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Model accurately predicts cyclodextrin formulation stability
The model determines cyclodextrin complex stability constants as a function of pH and temperature, helping to optimise formulations using cyclodextrin.
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AstraZeneca to invest $360 million in Irish manufacturing facility
The next-generation active pharmaceutical ingredient manufacturing facility should meet the needs for AstraZeneca’s new medicines pipeline.
