Manufacturing

Resin Selection to Optimize the Flexural Strength of Bioprocess Film

Abstract Single-use bioprocess technology offers several advantages for manufacturing biopharmaceuticals, such as increased transportability of fluids throughout the bioprocess workflow and a greater diversity of systems to support specific unit operations, e.g., rocking bioreactors. However, due to the flexible nature of the plastic materials used to construct the single-use containers, the flexural properties of the bioprocess film are critical for performance in such applications. This document focuses on how the resin selection and architecture of a bioprocess film can be…

Scaling Up Clinical T cell Expansion in a Xuri™ Cell Expansion System

Administration of antigen-specific T cells (ASTs), in particular for viral infections in transplantation, is one of the key focuses in immunotherapy. The Xuri™ Cell Expansion System can be used as an alternative to static cell culture methods for the stimulation and expansion of ASTs. The process described here demonstrates the use of the Xuri Cell Expansion System from the initiation of culture to the generation of virus-specific T cells. This includes a semi-static phase for antigen stimulation, a rocking phase…

Efficient Strategies to Deliver Reliable and High Quality Biomanufacturing Processes Through Optimization of Cell Culture Media, Feeds, and Process Parameters

Development of a reliable and high quality biomanufacturing process for recombinant CHO cell lines presents challenges from diverse nutritional requirements observed with different clonally derived cell lines, and variable response to process operating ranges. To address these challenges, we will discuss efficient approaches to optimize CHO cell culture media, feeds, and process parameters within FUJIFILM Diosynth Biotechnologies (FDB). Also discussed is FDB’s new ApolloTM CHO expression system, a cornerstone of process scale-up efficiency offering robust gene expression in a platform…