European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Yet in 2021, 100 nanomedicines had been marketed. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing.

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Process Improvement Packaging Vaccines FDA 70

European Pharmaceutical Review

FEBRUARY 12, 2024

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

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ISPE

SEPTEMBER 11, 2023

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). 1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

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. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

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. “Oligonucleotide Therapeutics: From Discovery and Development to Patentability.” Pharmaceutics 14, no. 2 (February 2022): 260.

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Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52