CTM CRC The CRC for Cell Therapy Manufacturing
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CTM CRC The CRC for Cell Therapy Manufacturing (CTM CRC) is a $60 M collaboration between industry, academia and health providers Vision: To increase the accessibility, affordability and efficacy of cell therapies Mission: CTM CRC’s mission is to ensure more efficient and cost-effective cell isolation, expansion and delivery by: § Developing novel technologies that integrate smart materials and interfaces for improved cell processes § Facilitating the pilot scale-up and translation of technologies
CTM CRC Capabilities • Manipulate cellular behaviour through interaction with functionalised surfaces • Development and optimisation of advanced surfaces and analysis • Biomaterials design • Bioanalytical expertise • Regulatory expertise • Preclinical experience • Pilot-scale expansion and manufacturing Technology Applications Adult progenitor cell expansion – Functionalised surfaces for more efficient large-scale expansion of cells, such as MSCs Controlled delivery of ancillary reagents – Specialised surfaces for more efficient supply of critical and expensive reagents for cell growth Topical delivery of adult progenitor cells – Surfaces that allow targeted delivery of cell therapies to specific sites of action for improved efficacy Antifouling surfaces – Reducing incidence of thrombosis and restenosis of vascular/coronary stents Pluripotent stem cells – Surfaces to promote expansion and targeted differentiation of cells, such as i. PS cells T cells – Activation, expansion and delivery
Development Themes Cellular Immunotherapies Materials & Interfaces • Cheaper and more practical cell isolation, expansion and delivery technologies, through the use of smart materials and functionalised surfaces • Addresses the efficacy, manufacturing and delivery challenges facing the T cell therapy industry Pilot Manufacturing CTM CRC • Scale-up of surfacefunctionalisation and cell expansion capabilities for proof-of-concept studies and rapid translation of technologies
Biomaterials Plasma treatment (chemical coating) Electrospun scaffolds Materials capabilities can be tailored to suit a range of expansion technologies and cell types: • Adult progenitor cells • T cells • i. PS cells Hydrophobic scaffolds Hydrogel scaffolds 3 D Lattices
#2 Topical Delivery of Progenitor Cells Product concept: Delivering cells from a dressing adult progenitor cells medical grade backing PP treated surface frozen and stored wound treatment PATENT PENDING
#3 Antifouling & Cell-attracting Surfaces Functionalised surfaces for improved vascular repair § Improvement in performance of vascular stents by § Reducing incidence of thrombosis/re-stenosis § Increasing re-endothelialisation of vessel walls § Patented process for coating bare metal stents § Reduces fouling of stent struts § Allows for functionalisation of stent with biomolecules to promote re-endothelialisation
Cellular Immunotherapies T cell expansion- Novel material for the ex vivo expansion of T cells, designed to integrate into existing T cell expansion platforms Cancer target for CAR-T therapy –Specific cancer antigen as a potential CAR-T cell target for the treatment of solid tumours Tregs for immunomodulation – Expansion protocols for a more stable Treg phenotype Targeted delivery – Surfaces and gels to allow targeted delivery of cells to sites of action for improved efficacy and reduced dose Gene delivery – Devices and technologies to improve delivery of DNA/RNA into cells, for cell and gene therapies
Cellular Immunotherapies #4 CTM CRC capabilities utilised across immunotherapy manufacturing PATENT PENDING Novel CAR-T cell target 1 Leukapheresis 2 Selection & Activation 3 D lattice for T-cell activation PATENT PENDING 3 Gene Transfer High efficiency (>90%) Tcell transformation methods which can be automated 4 Cell Expansion 3 D lattice for T-cell expansion which matches or exceeds magnetic bead performance & suitable for automation 5 Delivery Phase-shifting gel for delivery of CAR-T to tumour resection sites
Pilot Manufacturing Tek. Cyte. TM is a CTM CRC translational and pilotscale manufacturing facility to facilitate new technology development and translation into the clinic § § § Validation of lab-based technologies at a larger scale, prior to more expensive product development and commercial scale-up More accurate modelling and comparison of impact on manufacturing costs Critical infrastructure to deliver specialist training in c. GMP manufacturing of advanced therapies to private- and publicsector organisations 71% 79% 86% 97%
Pilot Manufacturing Tek. Cyte. TM Systems to test CTM CRC technologies Dedicated cleanroom suite including two Grade B c. GMP-standard manufacturing suites § Designed to meet international standard ISO 14644 and follow the PIC/S guide to GMP of medicinal products, Annex 1 § Separate AHU supply allowing for two simultaneous manufacturing activities § Transparent glass wall and AV facilities provide view into clean room for training purposes 71% 79% 86% 97%
Contact CTM CRC for Cell Therapy Manufacturing Level 5 Catherine Helen Spence Building Uni. SA City West Campus Adelaide SA 5000 T +61 8 8302 3503 E info@ctmcrc. com
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