2. CTM CRC
The CRC for Cell Therapy Manufacturing (CTM CRC) is a $60M 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

3. CTM CRC Capabilities Technology Applications
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
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 iPS cells
T cells – Activation, expansion and delivery

4. Development Themes CTM CRC Materials & Interfaces
Cellular Immunotherapies
Pilot Manufacturing
Addresses the efficacy, manufacturing and delivery challenges facing the T cell therapy industry
Cheaper and more practical cell isolation, expansion and delivery technologies, through the use of smart materials and functionalised surfaces
Scale-up of surface-functionalisation and cell expansion capabilities for proof-of-concept studies and rapid translation of technologies

5. Biomaterials Plasma treatment (chemical coating) Electrospun scaffolds
Hydrophobic scaffolds
Hydrogel scaffolds
3D Lattices
Materials capabilities can be tailored to suit a range of expansion technologies and cell types:
Adult progenitor cells
T cells
iPS cells

6. Topical Delivery of Progenitor Cells#2
Product concept: Delivering cells from a dressing
adult progenitor cells
PP treated surface
medical grade backing
Product concept is a simple one and very similar to Apligraf:
Cells are seeded onto the plasma polymer coated medical grade dressing
The cells and dressing are frozen and stored
Frozen cell-based dressing is shipped to wound clinics and hospitals as an off-the-shelf product to treat a variety of wounds.
Cells do not need to be expanded on the dressing, but simply seeded and then frozen. COGs for such a product can be maintained to under $1000 per treatment
frozen and stored
wound treatment
PATENT PENDING

7. Antifouling & Cell-attracting Surfaces#3
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
Ancillary materials can be a proportionally large component of COGs for allogeneic therapies.
Growth factors and cytokines are routinely added and the cost at the required standard can be at least $1M/g
Their use is very often sub-optimal; simply adding it to the medium at a specific concentration. As processes are scaled up the requirement for medium and therefore, these components, can become a large proportion of the cost of manufacture.
Scale non-optimal process →inefficiency increases
We know that many such bioactive molecules interact with the ECM and are delivered to the tissue in a spatio-temporal manner. We are trying to emulate this somewhat through the development of coated surfaces suitable for the correct delivery of GFs to cells. In most cases cells are attached to a surface or matrix so why not provide the factors on this surface?
This approach is applicable to a large number of factors used to expand CTs (FGF2, VEGF, IL2) with spatially and temporally control and to a large number of cell types.

8. 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
Ancillary materials can be a proportionally large component of COGs for allogeneic therapies.
Growth factors and cytokines are routinely added and the cost at the required standard can be at least $1M/g
Their use is very often sub-optimal; simply adding it to the medium at a specific concentration. As processes are scaled up the requirement for medium and therefore, these components, can become a large proportion of the cost of manufacture.
Scale non-optimal process →inefficiency increases
We know that many such bioactive molecules interact with the ECM and are delivered to the tissue in a spatio-temporal manner. We are trying to emulate this somewhat through the development of coated surfaces suitable for the correct delivery of GFs to cells. In most cases cells are attached to a surface or matrix so why not provide the factors on this surface?
This approach is applicable to a large number of factors used to expand CTs (FGF2, VEGF, IL2) with spatially and temporally control and to a large number of cell types.

9. Cellular Immunotherapies#4
CTM CRC capabilities utilised across immunotherapy manufacturing
Novel CAR-T cell target
PATENT PENDING
Leukapheresis 1
Selection & Activation 2
Gene Transfer 3
Cell Expansion 4
Delivery 5
3D lattice for T-cell activation
High efficiency (>90%) T-cell transformation methods which can be automated
3D lattice for T-cell expansion which matches or exceeds magnetic bead performance & suitable for automation
Phase-shifting gel for delivery of CAR-T to tumour resection sites
PATENT PENDING

10. Pilot Manufacturing TekCyteTM
TekCyteTM is a CTM CRC translational and pilot-scale 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 cGMP manufacturing of advanced therapies to private- and public-sector organisations
71%
79%
Ancillary materials can be a proportionally large component of COGs for allogeneic therapies.
Growth factors and cytokines are routinely added and the cost at the required standard can be at least $1M/g
Their use is very often sub-optimal; simply adding it to the medium at a specific concentration. As processes are scaled up the requirement for medium and therefore, these components, can become a large proportion of the cost of manufacture.
Scale non-optimal process →inefficiency increases
We know that many such bioactive molecules interact with the ECM and are delivered to the tissue in a spatio-temporal manner. We are trying to emulate this somewhat through the development of coated surfaces suitable for the correct delivery of GFs to cells. In most cases cells are attached to a surface or matrix so why not provide the factors on this surface?
This approach is applicable to a large number of factors used to expand CTs (FGF2, VEGF, IL2) with spatially and temporally control and to a large number of cell types.
86%
97%

11. Pilot Manufacturing TekCyteTM
Systems to test CTM CRC technologies
Dedicated cleanroom suite including two Grade B cGMP-standard manufacturing suites
Designed to meet international standard ISO 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%
Ancillary materials can be a proportionally large component of COGs for allogeneic therapies.
Growth factors and cytokines are routinely added and the cost at the required standard can be at least $1M/g
Their use is very often sub-optimal; simply adding it to the medium at a specific concentration. As processes are scaled up the requirement for medium and therefore, these components, can become a large proportion of the cost of manufacture.
Scale non-optimal process →inefficiency increases
We know that many such bioactive molecules interact with the ECM and are delivered to the tissue in a spatio-temporal manner. We are trying to emulate this somewhat through the development of coated surfaces suitable for the correct delivery of GFs to cells. In most cases cells are attached to a surface or matrix so why not provide the factors on this surface?
This approach is applicable to a large number of factors used to expand CTs (FGF2, VEGF, IL2) with spatially and temporally control and to a large number of cell types.
86%
97%

12. Contact CTM CRC T E