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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 EMA had provided a positive opinion for this marketing authorization back in July. Regulatory decisions come in. NICE decisions.

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Chinese manufacturers’ transition to innovative pharma requires more investment

Pharmaceutical Technology

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is still a considerable need for variant-specific boosters. Commercial dose manufacturing.

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Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

Manufacturing a drug therapy usually involves several different stakeholders. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. Regulatory decisions by the EMA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

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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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CMO Moves: Regulatory catalysts for therapy manufacturing -January

Pharmaceutical Technology

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.