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Bomb scare sparks evacuation of plant making AZ COVID-19 vaccine

pharmaphorum

A plant in Wales manufacturing the AstraZeneca COVID-19 vaccine was evacuated on the advice of the authorities today after it was sent a suspicious package. Wockhardt UK in Wrexham this morning received a suspicious package. Wockhardt UK in Wrexham this morning received a suspicious package.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” One case of drug contamination from 2021 was highlighted in the paper. Ahmed et al.

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Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Outsourcing may also be pursued if it is more favourable in terms of time and/or cost.

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Ocugen gets a black eye as FDA denies emergency OK for COVID jab

pharmaphorum

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. — FDA Biologics (@FDACBER) May 25, 2021. That includes the more transmissible B.1.617.2

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Sanofi to sell Japanese manufacturing plant

European Pharmaceutical Review

Historically, the 50-year-old site produced oral solids, sterile liquids, packaged products and offered retesting services to the Japanese and Asian markets. Sanofi states its work currently focuses on the research and development of vaccines, therapies for immunological, oncological and neurological disorders and medicines for rare diseases.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Covid-19 vaccines stay in the spotlight.

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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Yet in 2021, 100 nanomedicines had been marketed. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al. Significance of Annex 1–2022 for implementing Pharma 4.0