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 manufacturer drug products​
• United States Pharmacopeia (USP) <383>