TEST METHOD DEVELOPMENT FOR NEXT-GENERATION SINGLE-USE BIOPROCESSING APPLICATIONS

摘要

As single use disposable (SUD) bioprocessing systems become more commonplace, the range of applications and workflow steps served by single use continues to grow. Nearly all of the process steps and techniques currently used in bioprocessing were developed on stainless steel or glass vessels which exhibit thermal, chemical and mechanical properties which differ greatly from the polymer films used in SUD. While in many cases (e.g., cell culture) these differences have negligible effects on performance, as the industry pushes the limits of intensification and increases in the breadth of SUD applications (antibody-drug conjugation - ADC, microbial culture, etc.) single-use materials and systems face new challenges. This highlights the need for testing capabilities to qualify and develop new SUD materials, components and systems to ensure integrity, cleanliness and performance.