BioPharm International November 2023, Volume 36, Issue 11
Considering the Promises of Point-of-Care Manufacturing
~~ Published on: November 1, 2023, Jennifer Markarian
BioPharm International, BioPharm International, November 2023, Volume 36, Issue 11, Pages: 8-11 ~~
Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.
Although 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 point-of-care (POC) locations. POC manufacturing is seen as essential for efficiency in producing personalized medicines. In the near-term future, POC production is likely to be in a controlled environment such as a hospital, clinic, or pharmacy, while in the long term, POC production could extend to other locations. Such a model could enable quality drug production anywhere, from the battlefield to remote villages or even outer space, experts suggest.
The impetus for POC manufacturing comes in part from its potential to alleviate pressing problems, such as drug shortages, pandemic preparedness, and equitable availability of treatments. It is also driven by technological advances that promise to allow efficient and consistently high-quality production using new equipment, analytical tools, and quality control paradigms.
These technologies offer the benefit of making drugs much closer to where and when they are needed. "The advantages of making medicines on demand--to solve issues such as the difficulty of predicting demand and the complexity of the supply chain--are compelling," states Govind Rao, professor at the University of Maryland, Baltimore County (UMBC) and director of UMBC's Center for Advanced Sensor Technology.
FDA recognizes the need for flexible and agile manufacturing and sees the potential for portable, distributed manufacturing units to be used for POC manufacturing. 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 Biologics Evaluation and Research and called for public feedback (1). FDA and the Product Quality Research Institute (PQRI) also held a workshop in November 2022 to gather input from stakeholders. For advanced manufacturing technologies--particularly distributed manufacturing, POC manufacturing, artificial intelligence (AI), and end-to-end continuous manufacturing--seeking input is the first step in FDA's new Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative, according to a presentation by Michael Kopcha, director of CDER's Office of Pharmaceutical Quality (2).
Posted: November 15, 2023, 11:58 AM