Autologous manufacturing has long been thought of as resource-intense and therefore leading to high cost. As a result, autologous therapies are coming with a high price that is justified by exceptional efficacy. However, with the emergence of allogeneic therapies based on gene editing technologies, there is significant pressure on autologous therapies to become more cost efficient. This presentation will take a look at all aspects of potential cost savings.

Manufacturing autologous TCR-engineered T cell products requires multiple manipulations, specialized equipment, critical raw material, and complex supply chain logistics. Successful manufacturing with variable patient material warrants well-defined and thoroughly optimized process from the beginning. Key considerations such as quality of starting material, expansion platform, media and cytokine selection, optimized gene delivery, and manufacturing duration are critical for success in early stages and laying the foundation for advancement to pivotal and commercialization.

Maintaining high cell quality is still the challenge in autologous cell therapies manufacturing,  Manual manufacturing process is labour-intensive & oblivious to occur within the cell culture.

The ADVA-X3 platform learns the cell's metabolic behavior using Multiparameter sensing and Artificial Intelligence, adapts, controls & optimizes the physical conditions to reach maximal potential from each donor, based on pre-set parameters and protocol.

Recently the NCI has invested in establishing centralized manufacturing for cell therapy products to support multi-center clinical trials. This presentation will highlight the challenges of developing manufacturing and CMC support for autologous cell therapy products including: tech transfer, use of closed manufacturing systems, aseptic validations, process qualification, QC/QA rapid release, cryopreservation, and chain of custody logistics.

We describe here a well-established platform process for LV production based on transient transfection of serum-free cells grown in suspension. Both upstream and downstream processes are highly optimized to achieve optimal vector yields and significant decrease in the impurities (host cell protein/DNA, plasmid DNA). The compatibility of this platform process has been evaluated with multiple CAR/TCR genes while the robustness is demonstrated in reproducible runs at pilot scale.

Umoja aims to transform cancer care by creating an off-the-shelf, direct injection lentiviral vector (LVV) drug product for in vivo CAR T cell generation and expansion. We will present our approach to reproducible and scalable manufacturing of high-quality LVV, with special focus on expediting process development with risk-based quality documentation and impurity clearance at key process unit operations to meet ambitious final specifications.

This presentation will provide: Overview on the evolution of autologous facility design: the history, what’s happening right now, and what’s next; effective and efficient design considerations for scaling out autologous cell therapy; and facility strategies to save on square footage and cost

Allogeneic, off-the-shelf antigen-specific T cells have demonstrated promise by several academic and industry groups. However, manufacturing considerations for antigen-specific T cells vary from small-scale autologous or donor-directed T cells to large-scale off-the-shelf antigen-specific T cells. Here we will outline a number of considerations for manufacturing off-the-shelf T cells such as donor selection, scale, methods of characterization and assessing potency, and product testing and release.

CellPryme-M enhances adoptive cell therapy performance by shifting immune cells to a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumors. CellPryme-M is applied during the final 24 hours of CAR-T manufacture. The OmniCAR Universal Immune Receptor (UIR) platform significantly reduces CMC costs through creation of a single master CAR-Immune cell for ANY indication/target.

Unit Operations Approach to Improving cGMP Manufacturing of Tumor-Associated Antigen-Specific T Cells for Phase I Trials

This presentation examines state-of-the-art PAT implementation on standard physicochemical parameters in biopharmaceutical operations and considers potential cell therapy-related parameters that may be instrumental in overcoming the challenges of the current cell therapy manufacturing landscape. Current innovations applied to the field, such as high-throughput and high-dimensional analyses, machine learning, and novel sensor technologies, are also discussed.

Cellino’s vision is to make personalized regenerative medicines viable at large scale. Cellino’s platform combines label-free imaging and high-speed laser editing with machine learning to automate cell reprogramming, expansion, and differentiation in a closed cassette format, enabling thousands of patient samples to be processed in parallel in a single facility.

The LEAN manufacturing and management model, developed from the Toyota Production System (TPS), has triggered major transformations in various manufacturing industries. In this presentation, we provide practical examples to highlight the areas where such benefits can be achieved.