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Towards ‘smart’ vaccine development and manufacturing

European Pharmaceutical Review

However, the biopharma industries realised that traditional vaccine development and manufacturing techniques, which take around five to 10 years for initial development to large-scale distribution, 1 were inadequate to meet the growing demand for COVID-19 vaccines. Digital technologies for smart vaccine manufacturing.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Hospira recalls lot of Propofol Injectable Emulsion

European Pharmaceutical Review

The affected product was distributed nationwide to wholesalers, hospitals and Department of Defense in the US between 10 June 2020 and 26 June 2020. Wholesalers or hospitals with an existing inventory of the lot should stop use and distribution and quarantine immediately. The full details are listed below: Products. Lot Number.

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Meeting rising demands of a new radiotheranostic era

European Pharmaceutical Review

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Long production times and high energy costs in manufacturing are additional considerations.

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Ampoules packaging market forecast to 2033

European Pharmaceutical Review

Prospects of the ampoules packaging market On the other hand, advancements in ampoule packaging, as well as sustainability measures and manufacturing innovations such as automation and robotics, were highlighted as promising contributing factors for growth of the market.

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Improving aseptic connections throughout the manufacturing process

European Pharmaceutical Review

Aseptic is best applied to smaller, discrete techniques, behaviours and/or processes, eg, aseptic manufacturing and aseptic process simulation. It is not accurate to use ‘sterile’ to describe surfaces, methodologies, or environments such as biological safety cabinets and isolators.