The realities of manufacturing and commercialising cell therapies in Asia and the rest of the World
Progress in chimeric antigen receptor T (CAR T) cell therapies for hematopoietic malignancies has been stunning over the past decade, and solid tumors are only now catching up. One of the major challenges in the treatment of solid tumors with CAR T cells is the relative paucity of antigens selectively, let alone uniquely expressed by these cancers. In my talk I will briefly describe the development of the field, with an emphasis on how CAR T cell therapies have been evaluated in solid tumors, the antigens targeted; reasons why success has not been dramatic yet, and what the near future holds.
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Bioprocessing Technologies, Automation and Closed Systems - Applications and Case Studies
We have been developing an automated closed-cell culturing system using in-process monitoring. This system guarantees the quality of the cell products during processing by applying process analytical technology (PAT). Also, through data integration system in SCP, we can analyze trends of operations and QC test data of the products in process. SCP System is revolutionizing the current outdated and costly cell manufacturing approach and bringing breakthroughs to the medical field. In this session, we are introducing SCP System as a new cell manufacturing method focusing on industrializing and commercializing cell production for the generations to come
Informa is looking for 5 speakers to join our expert led discussion panel to talk on the below topics:
Process Automation and Closed Systems - Applications and Case Studies
Expansion cell culture, which is the most critical steps to realize the transplant of cells or tissues for cell therapy or regenerative medicine, respectively, will be done in terms of safety and cost-saving under the aseptic environment in the cell processing facility (CPF). The cell processing isolator system can enable cell processing in a closed aseptic chamber, which may reduce equipment and maintenance/operation costs while providing a reliable aseptic environment. In case of autologous cell processing, the CPFs are expected to handle cells collected from a large number of patients, and some believe that isolators with a function to prevent cross-contamination may be advantageous in providing a more reliable aseptic environment compared with open operation in the facilities. A novel isolator system based on a flexible Modular Platform (fMP) was designed to realize that the individual modules can connect and disconnect flexibly with keeping the aseptic environment inside each module, applying the cell processing. In addition, as it is known that the serial processes for cell processing affect the quality of the cells, the machinery processes are conducted not only to maintain an aseptic environment but also to lead to process stability in CPF. Thus, our attempts are concluded to build an advanced culture system employing isolator technology, and the adaptation of the fMP in CPF will lead to easy installation of the new modules for production line addition and/or revision through the clinical phases as well as commercial production, which contributes to the reduction of production costs.
Using single-use bioreactors to grow and differentiate pluripotent stem cells (PSCs) such as embryonic stem cells or induced pluripotent stem cells is considered a viable option for scale up of stem cell manufacturing process to commercial scale. PSCs are anchorage-dependent, and grow as aggregates or on microcarriers in a suspension culture, which makes them to be more susceptible to hydrodynamic shear stress compared to suspended single cells. Conventional stirred-type bioreactors with horizontal impellers require high agitation speeds and power inputs in order to fully suspend cell aggregates, which can negatively affect not only cell growth but also subsequent directed-differentiation in ways that may reduce cell growth rate, final product yield, quality, and potency. This problem becomes worse as bioreactor vessel size increases and is a key challenge for achieving satisfactory cell growth and differentiation outcomes for PSCs in bioreactors. A novel, single-use bioreactor system using Vertical-WheelTM technology has recently been introduced, which can achieve homogenous fluid mixing and uniform cell aggregate and microcarrier suspension using low agitation speeds and power inputs. The vertically-oriented mixing mechanism can consistently maintain a low shear environment across a full range of bioreactor working volumes and sizes, from 0.1 to 80 liters. The homogeneous distribution of turbulent energy dissipation rates inside a Vertical-Wheel bioreactor generates more uniform cell aggregates. In addition, the desired size of cell aggregates for optimal differentiation can be achieved by controlling agitation rate. Ultimately this can greatly increase the final yield of target cells, since the size of cell aggregates is critical for the kinetics and efficiency of directed differentiation. A homogeneous turbulent energy distribution and low hydrodynamic shear environment are unique benefits of Vertical-Wheel mixing and result in unparalleled scalability, from benchtop to commercial scale. Therefore, Vertical-Wheel bioreactor systems can be the ideal platform to develop robust manufacturing processes and scale up of shear-sensitive PSC products. These single-use Vertical-Wheel bioreactors have also demonstrated superior performance, compared to conventional stirred bioreactors, on the production of other cell therapy products including human mesenchymal stem cells and human chondrocytes grown on microcarriers. Results of Kolmogorov scale measurements, growth of anchorage-dependent cells, and differentiation yields of PSC's in various sizes of Vertical-Wheel bioreactors will be discussed in this presentation.
Reducing the Cost of Manufacturing - Costs of Goods Calculations and Considerations
WT1 is constantly expressed in leukemic cells of acute leukemia and myelodysplastic syndrome (MDS). A T-cell receptor (TCR) that specifically reacts with WT1 peptide in the context of HLA-A*24:02 has been identified. The safety and cell kinetics of WT1-specific TCR-gene transduced T cells in patients with acute myeloid leukemia (AML) and MDS were investigated in the first-in-human trial. In this talk, I will introduce our clinical trial and briefly overview the current status of redirecting T cells towards epitope/HLA complex for the treatment of hematological cancers including some of our own attempts.