Considering the Promises of Point-of-Care Manufacturing

Ithough biopharmaceutical production today generally takes place in centralized manufacturing facilities, industry and regulators are taking a close look at the benefits of decentralized or distributed manufacturing, which involves smaller and flexible-volume manufacturing operations in multiple loc...

Full description

Saved in:
Bibliographic Details
Published in:Pharmaceutical technology Europe 2023-11, Vol.35 (11), p.10-12
Main Author: Markarian, Jennifer
Format: Article
Language:English
Subjects:
Advanced manufacturing technologies
Artificial intelligence
Automation
Manufacturing
Product quality
Quality control
Quality standards
Raw materials
Regulatory agencies
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Ithough biopharmaceutical production today generally takes place in centralized manufacturing facilities, industry and regulators are taking a close look at the benefits of decentralized or distributed manufacturing, which involves smaller and flexible-volume manufacturing operations in multiple locations closer to the site of use and even to pointof-care (POC) locations. In October 2022, the Center for Drug Evaluation and Research (CDER) published a discussion paper that highlighted areas to consider for drugs regulated by CDER as well as the Center for Biologies Evaluation and Research and called for public feedback (1). Regulatory uncertainty is an ongoing challenge, with unanswered questions around how connected sites that are located in different regions will be regulated and a lack of global harmonization. Because no final guidance has been released by any regulatory agency, any differences in requirements are still unknown, Lamm cautions. Because of their agnostic nature, we can augment them to many modalities and even applications such as apheresis, if needed, to complete the full value chain."
ISSN:1753-7967