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Considerations for a Decentralized Manufacturing Paradigm

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4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 3 (2022):593–607. PDA Journal of Pharmaceutical Science and Technology 75, no.

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Oligonucleotides: A Cornerstone for Therapeutics & More

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Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Trudy Patterson.

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A Proposal for a Comprehensive Quality Overall Summary

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2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). raw materials, intermediates, DS, formulation, and packaging components, DP—against pre-defined specification criteria to confirm control.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). raw materials, intermediates, DS, formulation, and packaging components, DP—against pre-defined specification criteria to confirm control.

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Regulatory Landscape for Raw Materials: CMC Considerations

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Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 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. Jacqueline E.