Contact
2 avenue de la forêt de Haye
54505 Vandoeuvre-les-Nancy
France
Professeur des universités
About us
MTInov was created in 2020 from the association of the Cell Therapy and Tissue Bank Unit (UTCT) of the Nancy CHRU and the Bioprocesses and Biomolecules research axis of the Reaction and Process Engineering Laboratory (LRGP) of the CNRS and UL, This platform for studying, optimising and scaling up the production of cell-based biomedicines has expertise in cell culture in stirred bioreactors (monitoring, intensification, modelling, bioreactor design), as well as in the transfer to clinical grade in compliance with good manufacturing practice (GMP). The association of the UTCT and LRGP teams has resulted in a multidisciplinary partnership with complementary activities concerning both biotherapies/bioproduction and the development of bioprocesses to improve the yield and quality of cellular or cell-based products.
Business offer
The MTInov platform offers a full range of services, from support and regulatory advice to production and quality control.
Thanks to our experience in various research and clinical research projects, we are able to handle scale-up and industrialisation for different cell types: adherent cells (UC-MSC, BM-PSC) or in suspension (anti-viral T lymphocytes, CAR-T cells, NK cells, iNKT or MDSC). This enables us to offer you solutions tailored to the cell models you are working on. Adapting a 2D process to a 3D process, particularly in a bioreactor, right through to transfer to clinical grade conditions. The MTInov platform's areas of expertise therefore cover both the clinical-grade production of cell- or tissue-based drugs and the development of suspension or adherent culture processes in bioreactors.
This ensures continuity between pre-clinical development, scale-up and transfer to clinical grade in order to optimise production performance.
MTInov's long-term future depends on a number of factors, the most important of which are: the quality of the service provided, the ability to adapt premises capacity and production capacity in terms of staff to the demands of manufacturers, and the ability to raise funds to allow this flexibility. The quality of the service is based on the expertise and presence of competent, well-trained staff.
Our areas of expertise are listed below:
- - Clinical-grade production of cell therapy products in compliance with Good Tissue and Cell Practices (GTCP), clinical-grade production of Advanced Therapy Medicinal Products (ITMP-Punctually Prepared and ITMP-Experimental, as part of clinical trials) in compliance with Good Pharmaceutical Manufacturing Practices (GMP).
- - Quality control of cell products, including functional products.
- - Development of processes for the production of experimental ITMs.
- - Process engineering for human and animal cell culture in bioreactors.
- - On-line monitoring and control of bioreactor cultures.
- - Kinetic modelling, bioreactor extrapolation.
- - Numerical simulation of flows in cell culture bioreactors and bioreactor design.
- - Multi-scale modelling of interactions between MSCs and their culture medium.
Activities
- Research Unit
- Pre-industrial demonstrator
- Hematology
- Infectiology
- Immunology
- Inflammation
- Immunotherapy lead generation
- Manufacturability
- Production quality
- CMC
- Cell Culture
- Media composition
- Bioreactor conditions
- Cell expansion
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- pH
- Freeze/thaw
- Formulation
- Formulation
- Dose
- Stability
- Excipients
- Adjuvants
- Storage stability
- Clinical trials
- Phase I
- Phase II
- Regulatory filing
- Regulatory Filing
- Cell origin
- Single donor
- Pool of donors
- Cell Banking
- MSC
- CD34 + HSC cells
- Tissue acquisition
- Apheresis
- Target cell isolation
- Differentiated Cell
- Production Cell
- Cell modification
- Cell Activation
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- CMC/analytical quality assessment, quality control
- Cross contamination
- Sterility
- Deviations
- Contaminants detection
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Microcarrier-based culture
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Non-GMP expansion
- GMP expansion
- Purification/Extraction
- Filtration / microfiltration / ultrafiltration
- Centrifugation
- Chromatography
- Bioproduction modeling
- Metabolic / Kinetic modeling
- Control / command
- Global optimization
- Economic analyses
- Artificial Intelligence tools
- Formulation
- Conditioning
- Storage
- Delivery
- Transport
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Gene Delivery System
- Lentivirus
- Other Retrovirus
- Adoptive T Cell Major Challenges in Solid Tumors
- Microenvironment
- Cell procurement
- Autologous
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
