ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. 5’-(E)-Vinylphosphonate: A Stable Phosphate Mimic Can Improve the RNAi Activity of siRNA-GalNAc Conjugates.” 11 (2 June 2016): 985–89. Brigham, et al. “5’-(E)-Vinylphosphonate:

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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). 646 of 2016, 27 and the GHG Standard Scope 2. January 2016. 646 of 2016. Regulations 2016, Amendment, Energy Efficiency. 7 An integrative (vs. Recycling the Impossible.” August 2018.

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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. BioProcess International 14 (2016): 38–43. Smith, and R.

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ISPE

SEPTEMBER 11, 2023

12 April 2016. Pharmaceutical Processing World. Nature Communications 12, no. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. BioProcess International 14 (2016):38–43.

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ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. On this basis, country approvals covering 2016–2020 were included in the analysis. You may unsubscribe from these ISPE communications at any time.

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