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Inside the European mass shift to data-driven health solutions

Pharmaceutical Technology

“The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. These industries unexpectedly also included biotech, which was not a particularly strong area for Chinese manufacturing, which is more recognised for generics production.

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Message from the Chair an Exciting Year

ISPE

We defined the path forward for 2023–2025 after a final round of consultations with the Board advisors in July. In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Sanofi adds to biomanufacturing investment in France

European Pharmaceutical Review

At its Le Trait site in Normandy, Sanofi added that it will devote €100 million for new capacity for biologics formulation, filling, device assembly and packaging. Sanofi shared that it plans to launch in 2025. An investment of €250 million will used to build Europe’s largest flu vaccine production unit in Val de Reuil.

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2021: the year mRNA therapeutics came of age

pharmaphorum

It started with two Covid-19 vaccines – 2021 is the year interest in mRNA therapeutics boomed, reports Katrina Megget. The Covid-19 pandemic showed what could be done with resources and collaboration to accelerate the development of vaccines. There are multiple other mRNA vaccines that are being developed.

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