Cambridge Healthtech Instituteの第5回年次会議
Cell Therapy Manufacturing
2023年3月14 - 15日、CET（中部欧州標準時）
Registration and Morning Coffee07:00
ADVANCED MANUFACTURING PROCESSES
Manufacturing Enhancements with a Focus on Robustness, Quality, and Speed of TCR T Product Release
IMA203 & IMA203CD8 are Immatics’ TCR T product candidate(s) using a PRAME-specific TCR with or without a CD8 co-receptor. Manufacturing improvements implemented enhance key features of the cell product. Continuous enhancements are in progress in preparation of later-stage clinical trials.
Presentation to be Announced09:45
Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing10:00
A Consortium Investigation for the Implementation of PATs for Immunotherapy Manufacturing
There are longstanding challenges in the commercialisation of ATMPs that can be addressed by the implementation of process analytical technologies (PATs). Cell and Gene Therapy Catapult (CGTC) has led a consortium project with 23 collaborators to investigate the application of PAT and advanced analytics for a T-Cell immunotherapy process. We will describe results from the online, in-line and at-line PATs employed in the study discussing the different applications and implementations.
Integrated Manufacturing for Autologous and Allogenic Cell Therapeutics
Gene and cell therapies are gaining more and more interest in personalized precision medicine. From a manufacturing perspective, cell therapies are fairly demanding, requiring chemical gene synthesis, plasmid DNA fermentation and purification, along with viral vector design and production via mammalian cell cultures, isolation of human T cells from the patient or allogenic T cells, propagation of the T cells and transfection with the viral vector carrying the gene of interest for a ligand on the T cell surface targeting the T cell to the tumor cell to express their cytotoxic effect. Or coupling monoclonal antibodies to the surface of the T cell to target the tumor cell. An end-to-end supplier for all required manufacturing technologies is advisable and will facilitate the process chain.
Advanced Manufacturing Processes
Whether manual operation or a series of chained instruments, the lack of integration compromises speed, reproducibility, and quality of CGT therapy manufacturing. The CliniMACS Prodigy Platform automates and integrates the entire process workflow in a single device. With the example of a CAR T cell process, we will talk about the CliniMACS Prodigy with its flexibility and standardization for a resilient and scalable CGT production.
Human pluripotent stem cells (hPSCs) are a unique source for the production of functional human cell types, fueling advanced regenerative therapies. Bioreactors are a suitable platform to optimize cell culturing and to promote process development. In this talk, we show how to achieve cell densities of 35 X 106 cells/mL by precisely monitoring and controlling critical process parameters with Eppendorf bioprocess equipment. Pluripotency, differentiation potential, and karyotype stability were maintained.
Networking Lunch (Sponsor Opportunity Available)12:45
ADVANCED MANUFACTURING PROCESSES (CONT.)
Presentation to be Announced13:45
Decentralized Manufacturing and POCare Processing Platform
A roadmap to enabling cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis Point-of-Care (POCare) Platform enables a globally harmonized pathway for CGTs to reach large numbers of patients at the point of care at reduced costs through a data centric approach supporting scalable, and decentralized production. OMPULs (Orgenesis Mobile Production Units and Labs) are autonomous production units allowing rapid global deployment.
Scaling to Commercial Scale: Cord Blood Stem Cell Derived NK Cells (oNKord®)
Ongoing NK cell clinical trials suggest a therapeutic role for NK cells in various types of cancer. Impaired/dysfunctional immune cells in cancer patients highlight the need for an external supply of highly potent NK cells to repopulate the immune system. A scalable NK cell product, which is off the shelf and can be cryopreserved is the key to meet the unmet needs and for a successful commercialisation”. We will provide an overview of Glycostem’s allogeneic NK cell product oNKord® progress on the road to commercialisation.
A single dose of MSC therapy requires billions of cells, but traditional workflows that use 2D culture methods are inefficient at commercial scale. Scaling up microcarrier-based 3D suspension processes are significantly more sustainable, efficient and cost-effective. This presentation will explore the successful transition and scale-up from a 2D culture process to a 3D suspension-based platform to enable more sustainable production.
Refreshment Break in the Exhibit Hall with Poster Viewing15:20
End-to-End Automation Platform for the Manufacture of Complex Organoid-Based Implants
Organoid-based implant manufacturing may enable the production of complex 3D ATMP implants able to revolutionise defect regeneration and restore organ function. Engineering such complex ATMPs requires manufacturing technologies that can provide a robust backbone for phenotypic changes but also for increase in size. In this presentation a novel integrated and fully automated biomanufacturing platform will be showcased allowing the automated transition from single cells to organoids and finally to organoid-based 3D implants.
Biological Raw Material Sourcing for an Early Stage ATMP and Considerations for Late Stage Clinical Development
Amniotics has developed a MSC cell therapy for treatment of inflammatory lung diseases, currently tested in a Phase I clinical trial. The process uses multiple raw materials of biological origin, e.g., as source material (MSCs from amniotic fluid), sorting antibody, culture medium, detachment enzyme. Quality requirements, suitability for manufacturing of Phase I clinical material and supply issues are discussed here, as well as regulatory aspects and considerations for further development.
A Translational Services Business Model on the Grounds of Public Cell and Tissue Banking
Cell and tissue banks are establishments adhering to strict quality management standards and regulations, and we advocate its prominent role to enhance the value of donated Substances of Human Origin in innovative Advanced Therapy Medicinal Products. To achieve this, we have created a platform for collaboration with academic and industrial developers, supporting a range of activities from bioprocess design and Good Manufacturing Practice validation, to early phase I/II clinical trials.
Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.
Welcome Reception in the Exhibit Hall with Poster Viewing17:40
Close of Day18:45
Registration and Morning Coffee08:00
IMPACT OF BIG PHARMA
Harnessing the Capabilities of Big Pharma to Drive Cell Therapy
Newly created Biopharmaceuticals R&D Cell Therapy Department holds the ambition of developing and delivering cell therapies to address cardiovascular, renal, metabolic, respiratory, immunological, and rare disease. With focus on ex vivo manipulation of cells, the department continues to build on its diverse skillset, working cross functionally both internally and externally with collaborative partners to deliver therapeutic candidates coupled with innovative manufacturing building blocks to achieve clinical realisation.
LARGE-SCALE WORKFLOWS AND CRYOPRESERVATION
Development of an Allogenic Mesothelin CAR T Cell Therapy Production Process with a Representative Scale-down Model
CAR T cell therapy success in solid tumors has been limited due to the lack of tumor-specific antigens, to tumor heterogeneity, and to the immuno-inhibitory nature of the tumor microenvironment. To address these challenges, we engineered CAR T cells that use the tumor-specific mesothelin antigen as a discriminatory target and have enhanced therapeutic properties provided by multiple attributes. Its manufacturing method has been designed using a representative small-scale model that led to a new large-scale workflow.
Strategies for Cryopreservation and Banking of iPS Cells and Their Derivatives
Cryopreservation of iPS cells in large numbers or of functional, differentiated cells is also crucial for later success in therapy or other applications. Therefore, to meet the increasing demand in downstream applications, we have established robust, scalable cryopreservation protocols for iPS cells and several derivatives. This includes the use of large volume cryobags, ready-to-use formats and cryopreservation of tissue engineered products.
Coffee Break in the Exhibit Hall with Poster Viewing10:30
PLENARY SESSION: EMERGING MODALITIES, PLATFORMS, AND TECHNOLOGIES - FROM mRNA TO PROTEINS
基調講演：新興のモダリティ、プラットフォーム、技術 - mRNAからタンパク質へ
Overcoming CMC and Supply Chain Challenges for mRNA Technologies
Thanks to the rapid development of mRNA vaccines for COVID-19, the industry now has the momentum and resources to overcome many of the early CMC challenges and realize its enormous potential. This presentation will discuss the strategies in place to overcome CMC and supply chain challenges for mRNA technologies already and future innovations primed to take it to the next level.
Affinity Proteins for Biotechnological and Medical Purposes
Affinity proteins are crucial for life, for building structures, performing reactions, and for signaling purposes. In life sciences and medicine, affinity proteins are used to generate knowledge, but also for diagnostic and therapeutic purposes. This talk will cover how antibodies and small affinity molecules can be used to map the human proteome, develop diagnostic tools for in vivo visualization as well as efficiently purify therapeutics based on antibodies.
Transition to Sessions12:20
Networking Lunch (Sponsor Opportunity Available)13:00
Close of Cell Therapy Manufacturing Conference14:00