Journal Name:
- Advance Research in Pharmaceuticals and Biologicals
| Author Name |
|---|
Abstract (2. Language):
For therapeutics administered by certain routes such as pulmonary delivery, plastic ampoules can offer many
advantages over glass ampoules, vials, or syringes. Plastic ampoules are manufactured using blow–fill–seal (BFS)
technology. The BFS process involves plastic extrusion, molding, aseptic filling, and hermetic sealing in one sequential
operation. Unlike small molecules, biological drug products, such as proteins or monoclonal antibodies, are more prone
to degradation during processing, which may result in loss of activity or safety concerns. The operating conditions for a
BFS process and the nature of plastic ampoules pose many challenges to the stability and integrity of biological drug
products. In this article, the authors discuss considerations in the development and manufacturing of biological products
using the BFS process, including potential product exposure to elevated temperature, requirements for leak detection,
and packaging operations. They also highlight challenges and strategies for BFS process characterization and validation
in the context of biopharmaceutical manufacturing.
Bookmark/Search this post with
FULL TEXT (PDF):
- 4