By Andrew Walsh, Thomas Altmann, Joshua Anthes, et al.
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
By rethinking cleanroom requirements and reducing resource-heavy sterilization steps, manufacturers can significantly lower their Environmental Cost of Ownership and futureproof their operations.
In the evolving world of biopharmaceutical manufacturing, explore how single-use filtration remains a vital yet overlooked process essential to ensuring product purity and patient safety.
Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.
Scaling up life-saving gene-edited cell therapies means tackling production inefficiencies. Overcoming the time-consuming and risky cell washing step is crucial for clinical and commercial success.
Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.
Metabolic pathways define immune cell roles, from glycolysis fueling inflammation to fatty acid oxidation sustaining memory and tolerance. Discover how energy metabolism shapes immune responses.
Gain insight into how a supplemented medium stored at room temperature for up to 72 hours maintained T cell expansion performance, showing consistent viability and marker expression.
Explore data collected from a study utilizing healthy donors in a typical CAR T cell processing workflow without a transduction step from a cross-site validation study.
Here, we outline the upstream and downstream workflows of the VirusExpress® platform for lentiviral vectors and how the workflows were optimized through experiment design and supplementary studies.
