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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

OCTOBER 27, 2022

Oligonucleotides are a cornerstone of a burgeoning class of drugs classified as nucleic acid therapeutics. Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. Figure 1 shows a typical block flow sequence of unit operations. 1 Moumné, L.,

Process Improvement

Process Improvement Packaging Dosage Compounding

Accommodating Multiple Modalities in the Same Facility

ISPE

OCTOBER 26, 2022

Business Need, Possible Modalities, and Manufacturing Scale. When a business need is being developed, it must be determined which modalities are of interest to the organization, how their manufacturing might be accommodated, and at what scale they should be manufactured. These processes may still have open aseptic steps.

Vaccines

Vaccines Compounding Documentation FDA

Oligonucleotides: A Cornerstone for Therapeutics & More

Accommodating Multiple Modalities in the Same Facility

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