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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

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

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). 7 International Society for Pharmaceutical Engineering. ISPE Regulatory. Langer, and R. Pharmaceutical Engineering 42 no. Robinson, G.

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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). 7 International Society for Pharmaceutical Engineering. ISPE Regulatory. Langer, and R. Pharmaceutical Engineering 42 no. Robinson, G.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. 3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. 18 May 2022.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Reader note: This article was originally submitted to Pharmaceutical Engineering® in January 2022.