BioPharm International-06-15-2018

Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.

An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.

Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.