Moving your stem cell therapy from research to the clinic
Advancements in stem cell research continue to shed light on the potential for how stem cells can be used for various clinical applications, including cell replacement therapies, immunomodulatory therapies, and many others. Whether you are developing an induced pluripotent stem cell (iPSC) based therapy or adult stem cell therapy, Thermo Fisher Scientific has the solutions to advance your research to the clinic and beyond. Advancing your stem cell therapy to the clinic requires careful raw material selection because the starting materials can significantly impact the properties of your final stem cell therapy product. We offer high-quality stem cell reagents, media, and solutions for a variety of applications.
iPSC workflow from isolation to characterization
iPSC isolation and reprogramming
The first step in iPSC–derived therapy generation is isolation and cultivation of the donor’s somatic cells. The cell type used for reprogramming is often determined by availability of donor tissue, and the ultimate purpose for the iPSCs being generated. Having a robust and versatile reprogramming solution that can be used across a wide range of cell types and origins can help manufacturers overcome some of the variables encountered due to donor cell health, streamlining the manufacturing process.
Successful generation of iPSCs can depend on many factors including the age, health and disease status of the donor, the viability and proliferation rate of the isolated somatic cells, and the cell type. It is important to choose a reprogramming system which can help to overcome some of these potential challenges.
Sendai virus–based reprogramming
Sendai virus–based CytoTune reprogramming kits are one of the most versatile and robust commercially available reprogramming systems and can be used to reprogram a wide range of cell types and origins. Additionally, the CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit is the first off-the-shelf reprogramming system designed for clinical and translational research.
Dynabeads Isolation kits
Gibco cell culture media
Cell Therapy Systems (CTS)—solutions designed to enable clinical and commercial cell and gene therapy.
iPSC cell engineering and gene transfer
Patient-derived iPSCs offer exciting potential for both cell therapy and in vitro disease modeling by enabling access to cell populations that are otherwise unavailable from living donors. With the recent discovery of site-specific gene editing, fully harnessing and leveraging this capability is fast approaching. iPSCs can be genetically altered at a specific locus using genome engineering tools such as CRISPR or TALEN. In addition to genome editing tools we also offer viral transduction solutions, lipid-based transfection reagents and electroporation tools.
Lipid-based transfection
PSC expansion, banking and recovery
Considerations for banking PSCs
Generation of a robust PSC bank can be an important precursor to downstream cell therapy applications. Towards this, utilizing a cryomedium enables large quantities of cells to be safely placed into long-term cryopreservation.
Recovery of cryopreserved PSCs
Careful handling of cryopreserved PSCs is critical to support post-thaw recovery while minimizing cell death. To reduce stress from osmotic shock when thawing PSCs in cryomedium, dropwise addition of fresh culture medium along with specialized supplements can enhance PSC attachment and recovery.
PSC growth and expansion
When expanding PSCs in routine culture, maintenance of pluripotency, trilineage differentiation potential and karyotypic stability are essential for success in downstream cell therapy applications.
Banking and recovery
Growth and expansion
- CTS Essential 8 Medium
- CTS Vitronectin (VTN-N) Recombinant Human Protein, Truncated
- CTS Versene Solution
- CTS TrypLE Select
- CTS RevitaCell Supplement
- CTS DPBS, without calcium chloride, without magnesium chloride
- Nunc TripleFlask Treated Cell Culture Flasks
- Nunc Cell Factory Systems
- Gibco PeproTech Growth Factors and Cytokines for Stem Cells
iPSC Differentiation
iPSCs can generate virtually unlimited numbers of differentiated cell types, including neurons, cardiomyocytes, and potentially any other cell type in the body. These differentiated cells can be used in a range of applications including basic research, drug discovery, or future therapeutic applications. Stem cell differentiation requires standardized culture methods to help ensure reproducible and reliable results. Gibco media, supplements, and substrates provide you with an easy-to-use, flexible set of tools for targeted differentiation to your desired cell lineage. Our differentiation portfolio helps simplify your workflow and provides you with more control, enabling for fast, more efficient systems.
To view the complete differentiation portfolio, go to thermofisher.com/differentiation.
- PSC Neural Induction Medium
- PSC Dopaminergic Neuron Differentiation Kit
- PSC Cardiomyocyte Differentiation Kit
- PSC Definitive Endoderm Induction Kit
- CTS B-27 Supplement XenoFree (50X)
- CultureOne Supplement (100X)
- CTS Essential 6 Medium
- Gibco PeproTech Growth Factors and Cytokines for iPSC Differentiation
Differentiation of iPSCs can be studied using EVOS Cell Imaging Systems.
Characterization and release testing
Appropriate iPSC therapy product characterization remains central to the successful development of safe and efficacious cell therapies. Regulatory agencies require release testing to confirm the identity, purity, potency and safety of cell-based products. Thorough characterization and release testing of master cell banks is essential for successful development of stem cell therapies. A typical characterization workflow includes assessing pluripotency, genomic stability, and safety. Typical required safety assays include sterility, mycoplasma, endotoxin, and adventitious viral testing. More in-depth safety assessments may include HLA and cancer hot spot testing. See the ICH guidelines for validation of analytical procedures.
- PluriTest-Compatible PrimeView Assays for Pluripotency Confirmation
- TaqMan hPSC Scorecard Assay
- KaryoStat Assays for Assessing Genomic Stability of PSC Lines
- Oncomine Comprehensive Assay v3M
- AmpFLSTR Identifiler Direct PCR Amplification Kit
- MycoSEQ Mycoplasma Detection Kit
- LinkSēq HLA Typing Kits
- Flow Cytometry
- EVOS Cell Imaging Systems
- Microplate Readers
iPSC isolation and reprogramming
The first step in iPSC–derived therapy generation is isolation and cultivation of the donor’s somatic cells. The cell type used for reprogramming is often determined by availability of donor tissue, and the ultimate purpose for the iPSCs being generated. Having a robust and versatile reprogramming solution that can be used across a wide range of cell types and origins can help manufacturers overcome some of the variables encountered due to donor cell health, streamlining the manufacturing process.
Successful generation of iPSCs can depend on many factors including the age, health and disease status of the donor, the viability and proliferation rate of the isolated somatic cells, and the cell type. It is important to choose a reprogramming system which can help to overcome some of these potential challenges.
Sendai virus–based reprogramming
Sendai virus–based CytoTune reprogramming kits are one of the most versatile and robust commercially available reprogramming systems and can be used to reprogram a wide range of cell types and origins. Additionally, the CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit is the first off-the-shelf reprogramming system designed for clinical and translational research.
Dynabeads Isolation kits
Gibco cell culture media
Cell Therapy Systems (CTS)—solutions designed to enable clinical and commercial cell and gene therapy.
iPSC cell engineering and gene transfer
Patient-derived iPSCs offer exciting potential for both cell therapy and in vitro disease modeling by enabling access to cell populations that are otherwise unavailable from living donors. With the recent discovery of site-specific gene editing, fully harnessing and leveraging this capability is fast approaching. iPSCs can be genetically altered at a specific locus using genome engineering tools such as CRISPR or TALEN. In addition to genome editing tools we also offer viral transduction solutions, lipid-based transfection reagents and electroporation tools.
Lipid-based transfection
PSC expansion, banking and recovery
Considerations for banking PSCs
Generation of a robust PSC bank can be an important precursor to downstream cell therapy applications. Towards this, utilizing a cryomedium enables large quantities of cells to be safely placed into long-term cryopreservation.
Recovery of cryopreserved PSCs
Careful handling of cryopreserved PSCs is critical to support post-thaw recovery while minimizing cell death. To reduce stress from osmotic shock when thawing PSCs in cryomedium, dropwise addition of fresh culture medium along with specialized supplements can enhance PSC attachment and recovery.
PSC growth and expansion
When expanding PSCs in routine culture, maintenance of pluripotency, trilineage differentiation potential and karyotypic stability are essential for success in downstream cell therapy applications.
Banking and recovery
Growth and expansion
- CTS Essential 8 Medium
- CTS Vitronectin (VTN-N) Recombinant Human Protein, Truncated
- CTS Versene Solution
- CTS TrypLE Select
- CTS RevitaCell Supplement
- CTS DPBS, without calcium chloride, without magnesium chloride
- Nunc TripleFlask Treated Cell Culture Flasks
- Nunc Cell Factory Systems
- Gibco PeproTech Growth Factors and Cytokines for Stem Cells
iPSC Differentiation
iPSCs can generate virtually unlimited numbers of differentiated cell types, including neurons, cardiomyocytes, and potentially any other cell type in the body. These differentiated cells can be used in a range of applications including basic research, drug discovery, or future therapeutic applications. Stem cell differentiation requires standardized culture methods to help ensure reproducible and reliable results. Gibco media, supplements, and substrates provide you with an easy-to-use, flexible set of tools for targeted differentiation to your desired cell lineage. Our differentiation portfolio helps simplify your workflow and provides you with more control, enabling for fast, more efficient systems.
To view the complete differentiation portfolio, go to thermofisher.com/differentiation.
- PSC Neural Induction Medium
- PSC Dopaminergic Neuron Differentiation Kit
- PSC Cardiomyocyte Differentiation Kit
- PSC Definitive Endoderm Induction Kit
- CTS B-27 Supplement XenoFree (50X)
- CultureOne Supplement (100X)
- CTS Essential 6 Medium
- Gibco PeproTech Growth Factors and Cytokines for iPSC Differentiation
Differentiation of iPSCs can be studied using EVOS Cell Imaging Systems.
Characterization and release testing
Appropriate iPSC therapy product characterization remains central to the successful development of safe and efficacious cell therapies. Regulatory agencies require release testing to confirm the identity, purity, potency and safety of cell-based products. Thorough characterization and release testing of master cell banks is essential for successful development of stem cell therapies. A typical characterization workflow includes assessing pluripotency, genomic stability, and safety. Typical required safety assays include sterility, mycoplasma, endotoxin, and adventitious viral testing. More in-depth safety assessments may include HLA and cancer hot spot testing. See the ICH guidelines for validation of analytical procedures.
- PluriTest-Compatible PrimeView Assays for Pluripotency Confirmation
- TaqMan hPSC Scorecard Assay
- KaryoStat Assays for Assessing Genomic Stability of PSC Lines
- Oncomine Comprehensive Assay v3M
- AmpFLSTR Identifiler Direct PCR Amplification Kit
- MycoSEQ Mycoplasma Detection Kit
- LinkSēq HLA Typing Kits
- Flow Cytometry
- EVOS Cell Imaging Systems
- Microplate Readers
Adult stem cell therapy workflow from isolation to characterization
Cell Therapy Systems—solutions designed to enable clinical and commercial GMP cell and gene therapy manufacturing
Cell isolation and culture
Hematopoietic stem cells (HSCs) and mesenchymal stromal cells (MSCs, also known as mesenchymal stem cells) are readily available from a variety of tissue sources and show potential to address many unmet medical needs including blood disorders and cancers (HSCs), tissue reconstruction and graft-versus-host-disease (MSCs).
HSC isolation and expansion products
- Dynabeads CD34 Positive Isolation Kit
- Negative cell isolation of untouched cells
- Media and reagents for HSC culture
- Research regeants for HSC culture
- StemPro-34 SFM (for downstream iPSC research applications)
General tissue sample preparation and cell isolation
- Tissue and sample preparation procedures
- Human cell isolation
- Cell isolation with Dynabeads and MagniSort Technology
MSC Expansion Products
Cell engineering and gene transfer
Mesenchymal stem cells can be genetically altered using lipid-base transfection, electroporation, viral approaches or genome engineering tools such as CRISPR or TALEN. Methods may vary by cell type and application, so a broad array of gene transfer tools is available for your needs.
Viral transduction
Lipid-based transfection
Cell counting
Prior to cell banking, a cell count should be performed. Total cell count should be determined in a manual, semi-automated or automated fashion.
- Countess II Automated Cell Counter
- EVOS Cell Imaging Systems
- CountBright Plus Absolute Counting Beads (flow cytometry based)
Once the cell number has been determined, the cells can be resuspended in final culture media system or prepared for cryopreservation.
Cryopreservation
Cryopreservation using defined, serum-free cryopreservation medium helps reduce the potential risk of adventitious agents or other animal-derived components being introduced to patients.
- CTS Dulbecco's Phosphate-Buffered Salines
- CTS PSC Cryomedium (recommended for HSCs)
- StemPro MSC SFM XF + 10% DMSO (recommended for MSCs)
- CTS Synth-a-Freeze Medium
Characterization and release testing
Appropriate HSC and MSC therapy product characterization remains central to the successful development of safe and efficacious cell therapies. Potency and safety assays are largely therapy specific.
Flow cytometry is used to evaluate cell viability and surface marker expression throughout the workflow, including immediately after isolation, post-expansion and after recovery from cryopreservation.
- Flow Cytometry instruments and reagents
A standard flow cytometry workflow can involve:
For HSC, a sample flow cytometry panel utilizes*:
- CD34 monoclonal antibody clone 581
- CD90 (Thy-1) monoclonal antibody
- CD45RA monoclonal antibody, clone MEM-56
- Human Hematopoietic Lineage Antibody Cocktail
- LIVE/DEAD Fixable Yellow stain
*All listed products are available with additional fluorophores and/or clones; LIVE/DEAD Fixable stains are available for multiple excitation/emission ranges
For MSC, a flow cytometry panel may involve the following:
- Antibodies:
- Negative markers (all same fluorophore):
- LIVE/DEAD Fixable Yellow stain
In addition to surface marker expression, per ISCT guidelines (Dominici, M. et al. (2006) Cytotherapy, Volume 8, Issue 4, 315–317) MSCs must maintain trilineage differentiation capacity. In addition to surface marker expression, per ISCT guidelines (Dominici, M. et al. (2006) Cytotherapy, Volume 8, Issue 4, 315–317) MSCs must maintain trilineage differentiation capacity. Explore the EVOS Cell Imaging Systems and our Microplate Readers platforms for characterization and release testing of adult stem cells.
Cell isolation and culture
Hematopoietic stem cells (HSCs) and mesenchymal stromal cells (MSCs, also known as mesenchymal stem cells) are readily available from a variety of tissue sources and show potential to address many unmet medical needs including blood disorders and cancers (HSCs), tissue reconstruction and graft-versus-host-disease (MSCs).
HSC isolation and expansion products
- Dynabeads CD34 Positive Isolation Kit
- Negative cell isolation of untouched cells
- Media and reagents for HSC culture
- Research regeants for HSC culture
- StemPro-34 SFM (for downstream iPSC research applications)
General tissue sample preparation and cell isolation
- Tissue and sample preparation procedures
- Human cell isolation
- Cell isolation with Dynabeads and MagniSort Technology
MSC Expansion Products
Cell engineering and gene transfer
Mesenchymal stem cells can be genetically altered using lipid-base transfection, electroporation, viral approaches or genome engineering tools such as CRISPR or TALEN. Methods may vary by cell type and application, so a broad array of gene transfer tools is available for your needs.
Viral transduction
Lipid-based transfection
Cell counting
Prior to cell banking, a cell count should be performed. Total cell count should be determined in a manual, semi-automated or automated fashion.
- Countess II Automated Cell Counter
- EVOS Cell Imaging Systems
- CountBright Plus Absolute Counting Beads (flow cytometry based)
Once the cell number has been determined, the cells can be resuspended in final culture media system or prepared for cryopreservation.
Cryopreservation
Cryopreservation using defined, serum-free cryopreservation medium helps reduce the potential risk of adventitious agents or other animal-derived components being introduced to patients.
- CTS Dulbecco's Phosphate-Buffered Salines
- CTS PSC Cryomedium (recommended for HSCs)
- StemPro MSC SFM XF + 10% DMSO (recommended for MSCs)
- CTS Synth-a-Freeze Medium
Characterization and release testing
Appropriate HSC and MSC therapy product characterization remains central to the successful development of safe and efficacious cell therapies. Potency and safety assays are largely therapy specific.
Flow cytometry is used to evaluate cell viability and surface marker expression throughout the workflow, including immediately after isolation, post-expansion and after recovery from cryopreservation.
- Flow Cytometry instruments and reagents
A standard flow cytometry workflow can involve:
For HSC, a sample flow cytometry panel utilizes*:
- CD34 monoclonal antibody clone 581
- CD90 (Thy-1) monoclonal antibody
- CD45RA monoclonal antibody, clone MEM-56
- Human Hematopoietic Lineage Antibody Cocktail
- LIVE/DEAD Fixable Yellow stain
*All listed products are available with additional fluorophores and/or clones; LIVE/DEAD Fixable stains are available for multiple excitation/emission ranges
For MSC, a flow cytometry panel may involve the following:
- Antibodies:
- Negative markers (all same fluorophore):
- LIVE/DEAD Fixable Yellow stain
In addition to surface marker expression, per ISCT guidelines (Dominici, M. et al. (2006) Cytotherapy, Volume 8, Issue 4, 315–317) MSCs must maintain trilineage differentiation capacity. In addition to surface marker expression, per ISCT guidelines (Dominici, M. et al. (2006) Cytotherapy, Volume 8, Issue 4, 315–317) MSCs must maintain trilineage differentiation capacity. Explore the EVOS Cell Imaging Systems and our Microplate Readers platforms for characterization and release testing of adult stem cells.
Intended uses of the products mentioned on the page vary.
For specific intended use statements, please refer to the product label.
Cell therapy innovations
Explore our portfolio of innovative, scalable, purpose-built, cell therapy solutions that help ensure maximum productivity, consistency and reliability across your entire workflow.
Gibco CTS Rotea Counterflow Centrifugation System
The multipurpose CTS Rotea Counterflow Centrifugation System offers exceptional flexibility in a cell therapy development and manufacturing system. This versatile system applied the proven counterflow centrifugation method to a broad range of cell processing applications, such as CAR-T therapy, stem cell therapy, and PBMC isolation. The CTS Rotea system is comprised of the instrument single-use kits and customizable software, constituting a high-throughput closed system.
Gibco CTS Xenon Electroporation System
The CTS Xenon Electroporation System offers reliable delivery of DNA, RNA, proteins, and other molecules into cells, with exceptional cell viability and recovery. This leads to efficient transfection and genome editing, even in hard-to-transfect cells. A choice of two single-use electroporation chambers of different capacities provides flexibility: the SingleShot chamber enables process development while the MultiShot cartridge can be used in a closed, commercial-scale transfection system that helps minimize contamination and human error while maximizing safety.
Gibco CTS DynaCellect Magnetic Separation System
The CTS DynaCellect Magnetic Separation System is a closed, automated isolation, activation, and bead removal system for cell therapy development and manufacturing. Together with fit-for-purpose consumables, it delivers high cell purity, recovery, and viability. As a standalone instrument or as part of a workflow, the operator-independent system can help you isolate the right cells and minimize failures in manufacturing while helping provide increased robustness and precision.
