Discover how a leading CDMO, Rentschler Biopharma, navigates both standard and complex biologics manufacturing challenges by focusing on innovation, quality, and client centricity. In this white paper, you will discover:

• Two case studies about successful development strategies for both a standard antibody fragment and a complex heterogeneous molecule for hematology
• Implementation of continuous bioprocessing techniques, including perfusion-mode manufacturing and cutting-edge scale-up strategies
• Advanced analytical approaches for ensuring product quality, starting with early-stage development and extending through clinical manufacturing
• Quality by Design (QbD) principles in modern biologics manufacturing, with an emphasis on Critical Quality Attribute (CQA) maintenance
• Solutions for technical challenges in upstream and downstream processing, including resin lifetime optimization and analytical method development

This paper provides experienced insights for biopharmaceutical professionals who are interested in optimizing their development and manufacturing processes without compromising on quality. It is a resource for process development scientists, analytical development specialists, manufacturing leads, biopharma executives, and anyone seeking insights into modern biologics manufacturing solutions.

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