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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. The monoclonal antibody (mAb) is already approved for treating paroxysmal nocturnal haemoglobinuria in children and adolescents. NICE decisions.

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Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

It is therefore to be expected that there are a far greater number of Chinese sites for API manufacturing for FDA and EMA innovator and biosimilar drugs than for dose manufacturing and packaging. Veklury’s API is being manufactured by Esteve Huayi Pharmaceutical (Zhejiang, China) and Flamma (Bergamo, Italy) in east coast sites.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions.

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Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time

Pfizer

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. They embarked on a sterilization process to make the vaccine safe for injection.

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Optimizing lyophilization cycle times and improving stability for complex injectables 

Pharmaceutical Technology

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. A great example is aspirin. United States.