Next Generation Bioprinting Platform - A Multimodal Approach for Bioprinting of Cartilaginous Multicellular Spheroids and Skin .pdf
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Poietis specializes in next-generation bioprinting technology for regenerative medicine, particularly in creating 3D bioprinted tissue constructs like skin substitutes. Their flagship product, Poieskin®, is an autologous dermo-epidermal skin substitute aimed at addressing limitations of traditional skin grafts, with significant market potential. The company has developed advanced bioprinting techniques and automated systems to enhance tissue engineering and production scalability.
Next Generation Bioprinting Platform - A Multimodal Approach for Bioprinting of Cartilaginous Multicellular Spheroids and Skin .pdf
- 1. Dr. Fabien Guillemot Co-Founder, CSO, President Poietis Next Generation Bioprinting Platform: A Multimodal Approach for Bioprinting of Cartilage Multicellular Spheroids and Skin
- 2. Webinar | Octo ber 2024 Audience Poll
- 3. Webinar | October 2024 3 © Poietis – Confidential Poietis at a glance Established in 2014 16 patent families Bordeaux (France) Interdisciplinary team 25 people www.poietis.com Bioprinters for R&D & for therapeutics fabrication Mission: Provide Bioprinting solutions to Research and Regenerative Medecine centers NGB-C NGB-R Tissue Therapeutics (e.g. Poieskin®)
- 4. Webinar | October 2024 4 © Poietis – Confidential Next-Generation Bioprinting (NGB): Bridging the gap between Structure and Function Extrusion Bioprinting 3D tissue architecture (from which functions stem) is dictated by the print-head setup: - the 3D spatial distribution of cells (i.e. position, local concentration, …) is statistically derived from cell concentration within bio-ink syringe. - the resolution is mainly defined by needle diameter (with strong limitations due to shear stress). Bridging the gap between structure and function in Biofabrication Boularaoui et al. Bioprinting, (2020) Printing 3D shapes Bioprinting becomes driven by Biology principles and the need to deal with tissue complexity, (no longer conditioned by the printing device), (→ programming tissue self-organization: 4D Bioprinting) NGB is a paradigm shift Next-Generation Bioprinting (NGB) Printing 3D tissue shapes + Control of internal tissue architecture and cell micro-environment at the cell scale Multiple cell types and ECM are organized according to an-isotropic and non-geometric patterns, as in human native tissues.
- 5. Webinar | October 2024 5 © Poietis – Confidential Laser-Assisted Bioprinting Technology Advantages2 ❶ High resolution ❷ High cell vitality ❸ High versatility Notes: (1) INSERM: French National Institute for Health & Medical Research - Resulting from 10 years of academic research at INSERM1 . - Validated on more than 30+ cell types and via animal tests. Laser pulses are used to deposit cell-containing droplets 5 (2) Nature Biotechnology 5 5 Laser-Assisted Bioprinting with a microfluidic cartridge Hydrogel Living cells Spheroids
- 6. Webinar | October 2024 6 © Poietis – Confidential Versatility – Precision - Resolution Viscosity/resolution Size/Printing mode Bio-ink Concentration µ(cpoise) N cells Single cell Hyaluronic acid Fibroblast / Keratinocyte Cell aggregates Exosomes Bovine Serum Albumine 1000 100 1 Size(µm) 400 20 0.05 C (Million/ml) 100 10 1
- 7. Webinar | October 2024 7 © Poietis – Confidential Automated LAB system for bioprinting multi-cellular tissue constructs Effector (for tissue plates) Microfluidic cartridges Automated pipette and cell reservoirs
- 8. Webinar | October 2024 8 © Poietis – Confidential NGB printers = LAB + Bioextrusion + Additional features High-end 6 axis robotic arm High precision GMP compliant Laser-Assisted Bioprinting head Multi-cellular cartridge Extrusion & UV printheads Compatible with 3-10mL syringes Thermoregulated (4-65°C) UV lamps (365 / 405 nm) High resolution in-line Microscope High resolution: 2.2µm FOV: 12x10mm ViewPrintTM function Biological Safety Cabinet Laminar flow Worktable with free space for bio-ink preparation and cell culture Unique software suite Zebr4DTM for tissue design NGB user-friendly interface
- 9. Webinar | October 2024 9 © Poietis – Confidential 1 3 2 1. Left Panel Positioning & designing 3D Shapes (3D envelops) onto a defined substrate 2. Right Panel Defining the Internal Tissue Architecture Select and define bio-ink Infill 3D shapes with layers... 3. Central Panel Link between 3D shapes and Internal Architecture View3D Tissues Constructs, Layers, Patterns on the selected substrate Manipulate, position, rotate tissue constructs with mouse, scroll wheel and/or main toolbar (6) 6 Zebr4D®: A Unique Tissue CAD Software to Design Complex Tissues 7 6. Menu Bar See functions next page 7. Main Toolbar See functions next page 4 4. Navigation Toolbar Select 1 layer 5. Statistics Provide information (ink volume required, etc.) for bioprinting 5
- 10. Webinar | October 2024 10 © Poietis – Confidential NGB-R Software 1 2 3 4 5 6 1. Monitoring Monitoring and setting sensors and NGB-R printer’s main functions 2. Toolbox Executing functions that can be performed independently of a printing sequence 3. Home Main page interface 4. Editor Editing job sequence and configuring jobs (e.g. bioprinting parameters setting) 5. Printer Managing job sequence execution 7. Logs Records of NGB-R activities 9. Admin Managing users 6. Autotests Quick printer functions diagnosis 7 4 5 8 9 8. About Managing software version
- 11. Webinar | October 2024 11 © Poietis – Confidential NGB-C Software: Manufacturing Procedures and Traceability Audit trail Print process Admin Maintenance Bioprinting Menu Tissue Procedure Selector Checkboxes for operators Monitoring
- 12. Webinar | October 2024 12 © Poietis – Confidential 3 NGB-R 2023: Launch of NGB bioprinters commercial deployment 2021 : installation of a NGB-C demonstrator International deployment NGB-R NGB-C x3 - H1 2023: First NGB-R installed in Europe - H2 2023: First commercial NGB-C installed First installation into an industrial company Distribution agreement in China (9X Bio) - H1 2024: First NGB-R installed in USA Distribution agreement in Germany (HVD) US distributor:
- 13. Webinar | October 2024 13 © Poietis – Confidential Skin Substitute Market Opportunity Skin substitutes market is a fast growing, under-penetrated sub-market of the advanced wound care market. In the US alone, this market was valued at ~$700m in 2016 and is projected to reach ~$1,150bn by 2020, expanding at a CAGR of 14,5%. Worldwide, the skin substitute market is valued $3bn. - Aging population - Greater incidence of comorbidities (diabetes, obesity, cardiovascular diseases) - Increasing acceptance of advanced technologies to treat complex wounds - Overall growth of Advanced wound care market Organogenesis Corporate presentation, 2019 Key drivers of skin substitute market: Resources used in treating wounds AWC Product Categories Skin Substiture Sub-Market Source: International Wound Journal (2016)
- 14. Webinar | October 2024 14 © Poietis – Confidential Standard-of-care (Split-Thickness Skin Graft - “autograft”) Limitations - Donor-site limitations - Aesthetic outcomes - Wound contraction - Pain STSG limitations: ~29,000 skin autografts in France per year Source scansante.fr
- 15. Webinar | October 2024 15 © Poietis – Confidential Poieskin® as the First Therapeutic Product 15 Poieskin : a 3D bioprinted autologous dermo-epidermal skin substitute indicated for permanent coverage of skin defects Indications Acute and chronic wounds, reconstructive surgery. Market opportunity +150m people worldwide suffer from chronic or acute wounds. Skin substitute Market: ~$3bn by 2020 (CAGR of 14,5 %). Competition No TE skin product (EU market). No autologous dermo-epidermal skin substitute (global market). Target Product Profile 40cm² | Stratified epidermis | 21 days availability. Expected benefits Overcome standard of care (autograft) limitations: donor-site issues, pain, aesthetic outcomes. Improve graft take and wound closure rate. Reduction of wound care expenses Phase I/IIa 12 patients. Endpoints: non adverse reactions, graft take and wound closure. Key partner Prof. F. SABATIER LCTC 15 Poieskin® 40cm² bioprinted dermo-epidermis skin substitute
- 16. Webinar | October 2024 16 © Poietis – Confidential Poieskin Manufacturing Process: Development & Scale-up Specifications As of 2019 As of today Size 0.8 cm² 40 cm² Thickness 150 µm 500-700 µm Bioprinting duration 8 hours 3.5 hours Number of manual operations +100 10 Process scale-up throughput (vol / h): x400 Bioprinting & Maturation - Human dermal fibroblasts and epidermal keratinocytes from patients skin biospy (4cm²) - Expanded before being formulated into bio-inks Cell extraction and expansion + Process upgrade with GMP grade media and materials
- 17. Webinar | October 2024 17 © Poietis – Confidential Quality Control Methods Biopskin study (25 patients) - Collagen structure - Cell identity and functionality - Batch-to-batch reproducibility - Function (continuous stratified epidermis)
- 18. Webinar | October 2024 18 © Poietis – Confidential Preclinical evaluation: in vivo efficacy proof of concept In vivo efficacy evaluation - Suturability - Graft take (from D4) - Contraction (imaging) - Histology (scoring with anatomopatholgists) Poieskin Human skin (Athymic mice, (vs. human graft)) In vivo efficacy proof of concept of a large-size bioprinted dermo-epidermal substitute for permanent wound coverage M. Abellan Lopez et al. Front. Bioeng. Biotechnol., 25 July 2023
- 19. Webinar | October 2024 19 © Poietis – Confidential Tech Transfer and Training at Marseille Hospital - Installation of NGB-C bioprinter in the production zone (Grade B) of the Cell Therapy Unit in Hôpital de la Conception, (LCTC-APHM, Marseille, France) - Qualification (incl. MPT) - Training (@Poietis and on site) - Production of first batches Coming: Phase I/IIa clinical trials
- 20. Webinar | October 2024 20 © Poietis – Confidential Bioprinted implants for cartilage repair EU H2020 BHC JOINT PROMISE Osteochondral implants fabricated via bottom-up assembly of skeletal stem cell aggregates differentiated into functional microtissues ---- Design and development of a robotic platform combining bioreactor, in process control and bioprinting technologies https://www.jointpromise.eu/
- 21. Webinar | October 2024 21 © Poietis – Confidential PickCellTM module for bioprinting spheroids Spheroid detection in cartridge Control system Pattern generation PickCellTM module
- 22. Webinar | October 2024 22 © Poietis – Confidential PickCellTM module for bioprinting spheroids Gabriella Nilsson Hall et al 2024 Biofabrication 16 04502912 Biocompatibility
- 23. Webinar | October 2024 23 © Poietis – Confidential Conclusions: Next-Generation Bioprinting (NGB) Reproducibility & Comparability Standardized fabrication Automatization & Point-of-Care Affordable treatments Resolution & Flexibility 3D complex, functional tissues Meeting needs in Tissue Engineering NGB Bioprinting Platform Robotization | Multi-modality | Laser | GMP-compliance SCAN or CLICK
- 24. Webinar | Octob er 2024 WWW.SCINTICA.C OM Q&A WWW.SCINTICA.COM Contact Us: Niloufar Khosravi, PhD Senior Product Manager nkhosravi@scintica.com Please enter your questions in the Q&A section Thank You!