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Top Pharmaceutical Technology News Stories of 2019 |
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While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
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Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
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The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.
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States oppose the company’s plans for a Chapter 11 settlement, which would restructure the company as a trust and cap funding to plaintiffs, Reuters and other news outlets report.
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A $1.7-billion acquisition of CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
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Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.
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The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
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Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
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FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
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CPhI Worldwide organizers have revealed that the 2020 edition of the pharma event will return to the Fiera Milano venue in Milan, Italy.
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Top Pharmaceutical Technology Feature Stories of 2019 |
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Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
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Active and intelligent packaging technologies benefit brand owners, caregivers, and patients.
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Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.
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Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.
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While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.
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Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
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Early adoption of the right approach to address solubility can deliver significant benefits.
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Front-end focus and new approaches are speeding scale-up and reducing costs, while scale-down and scale-out become increasingly important.
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Wearable and smart devices allow user-friendly subcutaneous drug delivery.
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FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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Leveraging vast quantities of analytical data requires digitalization and platform integration.
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Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
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Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.
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