Pharma Mirror

FEBRUARY 18, 2022

By Christopher Weikart, Chief Scientist, SiO2 Materials Science Even though drugs are meant to save lives, the primary packaging used for delivering drug therapies and vaccines may actually be putting us in danger. The post 7 Problems with Using Borosilicate Glass to Package Drugs appeared first on Pharma Mirror Magazine.

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ISPE

OCTOBER 26, 2022

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. Board members were most impressed by the state-of-the art technology and the use of robots in the processes.

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PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). LinkedIn Total experience: 31 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

ISPE

JANUARY 10, 2023

Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. Four proposed data packages and submission strategies follow.

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Packaging FDA Communication Vaccines 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients. Company Name.

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Documentation FDA Packaging Communication 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Regulatory. Company Name.

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Documentation FDA Communication Packaging 52

ISPE

OCTOBER 27, 2022

AAV vectors are commonly associated with in-vivo gene therapies; AdV vectors show promise for vaccine applications including oncolytic virotherapy; and LV vectors are commonly associated with such ex-vivo approaches as CAR-T cell therapy. Accessed 11 August 2022. Unlock Access to Member-Only Content. Company Name.

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