ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Journal of Pharmaceutical Sciences (2021). 2021.09.046.

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ISPE

OCTOBER 27, 2022

Towards Next Generation Antisense Oligonucleotides: Mesylphosphoramidate Modification Improves Therapeutic Index and Duration of Effect of Gapmer Antisense Oligonucleotides.” 16 (20 September 2021): 9026–41. You may unsubscribe from these ISPE communications at any time. Pharmaceutics 14, no. 2 (February 2022): 260. 2 CRB Group.

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ISPE

SEPTEMBER 11, 2023

1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. Nature Communications 12, no. 1 (2021):7200. 13 July 2021. Updated 22 July 2021. 2021, Washington, D.C.: Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” October 2022.

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ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Leave this field blank

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ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 14–25 (November–December 2021). 25 February 2021. BioProcess International 8 December 2021 (November–December 2021) [link] 23 Bio-Process Systems Alliance. 14 Whitford, W.

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ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

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