Overview
Originally presented at Bioprocess International 2025, CPC’s Maria Bollensen discusses how to mitigate risk using modular and single-use systems to reduce costs, increase productivity, improve quality, reduce risk, and increase flexibility in biopharmaceutical applications. Also, taking a deeper look at the new regulations supporting single-use technology; including BPOG guidelines, USP <665> and USP <383>.
Presentation overview
- Modularity as the building blocks to be prepared for anything in your production.
Quality assurance requirements
- New Regulations supporting single-use Technology
- United States Pharmacopeia (USP) <665>: Plastic components and systems Used to Manufacture Drug Products
- United States Pharmacopeia (USP) <383>