Moving your T cell manufacturing from research to the clinic and beyond
As more cell therapies are approved for commercial use, the number of potential therapies across a large range of applications has significantly increased. There is a critical and emergent need for specialized tools and solutions to enable manufacturers to overcome current challenges associated with this complex manufacturing process. Our portfolio of cell therapy specific tools, media, reagents and instruments help minimize the risk of contamination and manufacturing variability and provide extensive traceability documentation, including FDA Drug Master Files and Regulatory Support Files, helping to facilitate the transition from research to commercialization.
T cell therapy manufacturing workflow from isolation to characterization
CAR T cell processing, isolation and activation
The first step in manufacturing a T cell therapy—autologous or allogeneic—is to collect blood from a patient (or donor for allogeneic) and select out the cell type of interest.
Cell processing and wash/concentrate steps can be performed using a closed counterflow centrifugation cell processing system.
Cell isolation, activation and debeading can be done using the Gibco CTS DynaCellect Magnetic Separation system along with Gibco CTS Dynabeads magnetic beads, a trusted technology for the isolation and activation of T cells ex vivo. Select the correct Dynabeads for your work.
Once your T cells have been isolated, activated, and/or expanded, the CTS DynaCellect can be used to remove the magnetic beads.
CAR T cell engineering
The next step in the process may include genetic modification of your cells. Immune cells are traditionally difficult to transfect and may require specialized approaches. We offer a range of both viral and non-viral gene editing solutions, to suit your specific needs.
Viral vector solutions
We offer complete viral vector production solutions for high titer and cost-effective viral vector production for lentiviral (CTS LV-MAX production system) and adeno-associated viral vector production, (CTS AAV-MAX production system).
We also offer a range of downstream purification resins, including the POROS resins for AAV, and CaptureSelect Lenti VSVG Affinity Matrix, the first commercial affinity resin specifically designed for specific capture and gentle elution required for VSVG pseudotyped lentivirus particles.
Non-viral methods
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.
Genome editing tools and services
We offer both CRISPR-Cas9 and TAL effector genome editing tools because we know the best fit depends on your application, cell type, target gene, and delivery method. Our proven solutions are designed to help you accelerate your research. Whether you are looking to perform a gene knock-out, knock-in, activation, or repression - know that we have a solution for you.
CAR T cell culture
Whether working with a patient’s cells (autologous) or donor cells (allogeneic), maintaining the health of the cells during culture is paramount. Our extensive selection of Gibco CTS GMP-manufactured media and reagents are designed specifically for cell therapy manufacturing, and include serum-free media and serum replacement products to suit your unique workflow needs.
Media and supplements
- CTS OpTmizer One SFM
- CTS OpTmizer Pro SFM
- CTS OpTmizer T-Cell Expansion SFM
- CTS Detachable Dynabeads CD3/CD28
- CTS Detachable Dynabeads Release Buffer
- AIM V Serum Free Medium
- CTS Immune Cell Serum
- Gibco PeproTech Growth Factors and Cytokines for Immunology
Cell wash
- CTS DPBS, without calcium chloride, without magnesium chloride
Cell culture platforms
Fill and finish
Cell wash, fill, finish and transport are crucial steps of the cell therapy workflow. Prior to fill finish cell processing (wash/concentrate) can be performed using the CTS Rotea Counterflow Centrifugation System. Following necessary characterization and analytics, the final product is ready for final fill and finish. Thermo Fisher Scientific offers single-use solutions for fill, finish, storage, and transport. Our GMP-manufactured sterile containers combined with fluid transfer sets are suitable solutions for your immunotherapy process.
Our products include low-particulate glass- and plasticware that meet or exceed stringent USP <788> requirements. We offer standard and custom configured fluid transfer assemblies designed to fit your process needs. Whether you’re in research or clinical trial our single use technology will grow with your business.
Characterization and release testing
Appropriate cell 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. Typical required safety assays include sterility, mycoplasma, endotoxin, and adventitious viral testing.
Thermo Fisher Scientific provides a variety of robust, relevant assays based on commonly used technologies such as flow cytometry, real-time qPCR, and Luminex.
CAR T cell processing, isolation and activation
The first step in manufacturing a T cell therapy—autologous or allogeneic—is to collect blood from a patient (or donor for allogeneic) and select out the cell type of interest.
Cell processing and wash/concentrate steps can be performed using a closed counterflow centrifugation cell processing system.
Cell isolation, activation and debeading can be done using the Gibco CTS DynaCellect Magnetic Separation system along with Gibco CTS Dynabeads magnetic beads, a trusted technology for the isolation and activation of T cells ex vivo. Select the correct Dynabeads for your work.
Once your T cells have been isolated, activated, and/or expanded, the CTS DynaCellect can be used to remove the magnetic beads.
CAR T cell engineering
The next step in the process may include genetic modification of your cells. Immune cells are traditionally difficult to transfect and may require specialized approaches. We offer a range of both viral and non-viral gene editing solutions, to suit your specific needs.
Viral vector solutions
We offer complete viral vector production solutions for high titer and cost-effective viral vector production for lentiviral (CTS LV-MAX production system) and adeno-associated viral vector production, (CTS AAV-MAX production system).
We also offer a range of downstream purification resins, including the POROS resins for AAV, and CaptureSelect Lenti VSVG Affinity Matrix, the first commercial affinity resin specifically designed for specific capture and gentle elution required for VSVG pseudotyped lentivirus particles.
Non-viral methods
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.
Genome editing tools and services
We offer both CRISPR-Cas9 and TAL effector genome editing tools because we know the best fit depends on your application, cell type, target gene, and delivery method. Our proven solutions are designed to help you accelerate your research. Whether you are looking to perform a gene knock-out, knock-in, activation, or repression - know that we have a solution for you.
CAR T cell culture
Whether working with a patient’s cells (autologous) or donor cells (allogeneic), maintaining the health of the cells during culture is paramount. Our extensive selection of Gibco CTS GMP-manufactured media and reagents are designed specifically for cell therapy manufacturing, and include serum-free media and serum replacement products to suit your unique workflow needs.
Media and supplements
- CTS OpTmizer One SFM
- CTS OpTmizer Pro SFM
- CTS OpTmizer T-Cell Expansion SFM
- CTS Detachable Dynabeads CD3/CD28
- CTS Detachable Dynabeads Release Buffer
- AIM V Serum Free Medium
- CTS Immune Cell Serum
- Gibco PeproTech Growth Factors and Cytokines for Immunology
Cell wash
- CTS DPBS, without calcium chloride, without magnesium chloride
Cell culture platforms
Fill and finish
Cell wash, fill, finish and transport are crucial steps of the cell therapy workflow. Prior to fill finish cell processing (wash/concentrate) can be performed using the CTS Rotea Counterflow Centrifugation System. Following necessary characterization and analytics, the final product is ready for final fill and finish. Thermo Fisher Scientific offers single-use solutions for fill, finish, storage, and transport. Our GMP-manufactured sterile containers combined with fluid transfer sets are suitable solutions for your immunotherapy process.
Our products include low-particulate glass- and plasticware that meet or exceed stringent USP <788> requirements. We offer standard and custom configured fluid transfer assemblies designed to fit your process needs. Whether you’re in research or clinical trial our single use technology will grow with your business.
Characterization and release testing
Appropriate cell 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. Typical required safety assays include sterility, mycoplasma, endotoxin, and adventitious viral testing.
Thermo Fisher Scientific provides a variety of robust, relevant assays based on commonly used technologies such as flow cytometry, real-time qPCR, and Luminex.
Logistics, CMDO services, and clinical trial management
Our extensive CDMO and CRO services encompass a range of capabilities to support advancement of your therapy to the clinic. Following fill-finish, the product will need to be labeled and distributed either to the clinical site or to an interim storage location until the patient is ready to be dosed. Thermo Fisher Scientific’s global network of cGMP storage and distribution facilities allows us to support secondary packaging, labeling, transportation and distribution worldwide, whether it be immediate transportation from your manufacturing facility to clinical site via our in-house specialty courier, or off-site storage with just-in-time delivery upon patient enrollment to your clinical trial. Thermo Fisher Scientific has the logistics expertise required to help maintain the integrity of your materials, from cell collection to delivery to the patient.
Intended uses of the products mentioned on the page vary. For specific intended use statements, please refer to the product label.
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 minimizes 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.
