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EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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Drug Manufacturing
whitepaper
Whitepaper: Product characterisation: reveal your molecule earlier, faster and with accuracy
Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.
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New steps taken to lower US prescription drug prices
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
whitepaper
Application note: Cost review of water for injection systems
Vapour-compression-based WFI production has a total cost of ownership that is less than or equivalent to that of a membrane-based system and significantly less than that of a typical multiple-effect-based system. The following whitepaper provides examples that illustrate system designs that are relatively basic, yet typically sufficient.
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The global cannabinoid pharmaceutical industry
Cannabinoids are of growing interest in the pharmaceutical industry. Mark Tucker explains how this class of compounds is viewed across the world and why regulations surrounding them hinder their progress, yet remain necessary.
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Technique to manufacture virus-like particle polio vaccines developed
University of Leeds researchers have discovered a method to produce polio vaccines made from virus-like particles, which is being trialled on a manufacturing platform.
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Investment in UK cell and gene therapy manufacturing set to continue
An additional 6,000m2 of cell and gene therapy manufacturing space is expected to become available within the next 12 months, according to new data.
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New opportunities for Indian pharma industry in Philippines, finds study
The Philippines’ 2019 Universal Health Care Act and regulatory tax reforms open new avenues for the Indian pharmaceutical industry, according to new research.
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High levels of pharmaceutical pollution found in industrialising counties
A study has revealed that in industrialising and urbanising countries, pharmaceutical pollution in rivers could lead to antimicrobial resistance.
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The Brexit test: protecting pharmaceutical quality standards through better analysis
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.
whitepaper
Research Report: Industrial Transformation Challenging in Life Sciences
Industrial transformation is a very real phenomenon. Companies are going beyond standard practices to seek out step-change improvement in industrial operations, with several companies already reporting "dramatic results".
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Medical device design – a key consideration when entering biosimilars market
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
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Medicine regulators should increase collaboration, says new report
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
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Leaked document reveals ‘unprecedented’ medicine shortages in NHS
A document from the DHSC has reportedly advised NHS doctors to ration certain medicines after outlining dozens of drugs that are in shortage, as published in a report.
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Pernicious microorganisms: risks of contamination in pharma
Some pharmaceutical manufacturers can struggle to keep microorganisms away from their facilities, which sometimes goes unnoticed until it is too late. While there are numerous threatening microorganisms, this article focuses on some of the most troublesome, highlighting the hazards they pose and analysing how manufacturers can prevent microbial contamination in…
