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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
June 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.