Case Studies
G-Rex: Expanding the Capabilities of Scalability
When global events affected the availability of products used in the manufacture
of cell therapies, teams needed to explore alternative manufacturing methods. This supply chain crisis emphasized the need to establish redundant processes to address production obstacles for critical stages of cell therapy manufacturing.
Case Studies
Transition to Closed-system T Cell Expansion Leads to Process Optimization
In this case study, ScaleReady helped an autologous T cell therapy company rapidly transition to a closed-system process for cell expansion by providing a testing plan to verify that G-Rex500M-CS closed-system bioreactors would meet their immediate cell production requirements and improve cell production efficiency, while adhering to their short timelines for going into clinical trials. In doing so, the company also uncovered small changes to their cell culture protocols that made a big impact on their cell production efficiency.
Case Studies
Forecasting a Commercially Viable T Cell Therapy Manufacturing Process
In this case study, a company requested help from ScaleReady to build business case for G-Rex®500M-CS bioreactors as the primary cell production platform for their autologous TCR T cell therapy pipeline. ScaleReady modeled operational costs
for an autologous TCR T cell therapy company using G-Rex bioreactors. This provided transparency into long-term commercial
viability of the ScaleReady platform.
Case Studies
GMP Cytokines Optimization for Closed System T Cell Therapy Manufacturing
In this case study, a company focused on autologous T cell therapies targeting solid tumor cancers was progressing into clinical trials and needed to transition from research-grade to GMP-grade cytokines. Concurrently they wanted to improve
their methods of cytokine supplementation to reduce cytokine waste, improve dose accuracy across lots, and
reduce process risk by defining methods for closed-system cytokine addition. ScaleReady detailed a plan to help them achieve these goals.