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Meeting global demand for patient independence: SHL Medical expands production in Charleston, US

Pharmaceutical Technology

As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. Download the white paper ‘Charleston, USA: A life sciences hub’ here.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

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. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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CMO Moves: Regulatory catalysts for therapy manufacturing -January

Pharmaceutical Technology

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. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

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CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.