artist’s rendition of engineered T cells

Moving your immunotherapy from research to the clinic and beyond

With the recent surge of T cell–based immunotherapies, more researchers are taking interest in these specialized immune cells, particularly with respect to the development of chimeric antigen receptor T cell (CAR-T) therapies. Whether you’re developing a CAR-T therapy, another type of T cell immunotherapy, or working with other immune cell types, we can help you move from research to the clinic and beyond. Our cell culture media and reagents help minimize the risk of contamination and variability and provide extensive traceability documentation including FDA Drug Master Files and Regulatory Support Files to support regulatory review, helping to facilitate a seamless transition from research to commercialization. Our goal is to help you reduce the amount of time from initial discovery to approved therapy.

Immunotherapy workflow from isolation to characterization

process diagram showing the steps from cell isolation and activation to final fill and finish

We have an extensive selection of high-quality research use products to support your early cell therapy development. As you move toward clinical and commercial applications, our GMP-manufactured Cell Therapy Systems (CTS) products offer specific cell and gene therapy use statements, extensive safety testing and proactive regulatory documentation.

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Cell isolation and activation

The first step in manufacturing an immunotherapy–autologous or allogeneic–is to collect peripheral blood mononuclear cells (PBMCs) from a patient (or donor for allogeneic). The cells then need to be isolated from the other mononuclear cells. Gibco CTS Dynabeads magnetic beads are a trusted technology for the isolation, activation, and/or expansion of T cells ex vivo. Whether working with polyclonal T cells, antigen-specific T cells, gene-modified T cells, regulatory T cells, or other T cell subtypes, CTS Dynabeads magnetic beads enable the recovery of T cells with properties comparable to in vivo–activated T cells. Select the correct Dynabeads for your work.

Once the T cells have been isolated, activated, and/or expanded, the CTS DynaMag Magnet is then used to remove the magnetic beads.

Cell engineering

The next step may include genetically modifying your cells. Immune cells are traditionally difficult to transfect and may require specialized approaches. We offer cell engineering solutions for viral and non-viral gene editing, including transfection reagents, lentiviral transduction, electroporation, and gene editing tools.

Lentiviral methods

We offer complete solutions for high titer and cost-effective adherent and suspension vector production, including Invitrogen GeneArt Elements vector construction, and adherent and suspension lentiviral production solutions. Our scientists continue innovating to provide scalable solutions, such as Gibco LV-MAX Lentiviral Production System: the first complete suspension production system, which produces up to 10x more lentivirus than PEI-based systems and enables a cost reduction of more than 50%.

Non-viral methods

The Invitrogen Neon Transfection System delivers DNA, RNA, and protein into cells while avoiding the challenges faced by reagent and viral methods. By using the Neon system to optimize electroporation conditions and cell density, it is possible to achieve greater than 80% transfection efficiency with several blood cell lines as well as primary T 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 knockout, knock-in, activation, or repression, know that we have a solution for you. For those who are new to CRISPR gene editing, we offer the new TrueDesign Genome Editor, a hands-on workshop and educational resources to help you get started.

artist’s rendition of a DNA double helix

Cell culture

Once the cells have been isolated, they are cultured. Whether working with a patient’s cells (autologous) or donor cells (allogeneic), maintaining the health of the cells is paramount. Our extensive selection of Gibco CTS GMP-manufactured media and reagents are designed specifically for cell therapy manufacturing, including serum-free media and serum replacement. CTS cell culture media and reagents help minimize the risk of contamination and variability in your research and provide extensive traceability documentation including FDA Drug Master Files and Regulatory Support Files to support regulatory review, helping to facilitate a seamless transition from research to commercialization.

artist’s rendition cells and antibodies

Fill and finish

Cell wash, fill, finish and transport are crucial steps of the cell therapy workflow. It is essential to have high-quality reagents for cell wash. After the final product is washed and purified and has received regulatory approval, it 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, Luminex, NGS and others.

scientists in lab

Cell isolation and activation

The first step in manufacturing an immunotherapy–autologous or allogeneic–is to collect peripheral blood mononuclear cells (PBMCs) from a patient (or donor for allogeneic). The cells then need to be isolated from the other mononuclear cells. Gibco CTS Dynabeads magnetic beads are a trusted technology for the isolation, activation, and/or expansion of T cells ex vivo. Whether working with polyclonal T cells, antigen-specific T cells, gene-modified T cells, regulatory T cells, or other T cell subtypes, CTS Dynabeads magnetic beads enable the recovery of T cells with properties comparable to in vivo–activated T cells. Select the correct Dynabeads for your work.

Once the T cells have been isolated, activated, and/or expanded, the CTS DynaMag Magnet is then used to remove the magnetic beads.

Cell engineering

The next step may include genetically modifying your cells. Immune cells are traditionally difficult to transfect and may require specialized approaches. We offer cell engineering solutions for viral and non-viral gene editing, including transfection reagents, lentiviral transduction, electroporation, and gene editing tools.

Lentiviral methods

We offer complete solutions for high titer and cost-effective adherent and suspension vector production, including Invitrogen GeneArt Elements vector construction, and adherent and suspension lentiviral production solutions. Our scientists continue innovating to provide scalable solutions, such as Gibco LV-MAX Lentiviral Production System: the first complete suspension production system, which produces up to 10x more lentivirus than PEI-based systems and enables a cost reduction of more than 50%.

Non-viral methods

The Invitrogen Neon Transfection System delivers DNA, RNA, and protein into cells while avoiding the challenges faced by reagent and viral methods. By using the Neon system to optimize electroporation conditions and cell density, it is possible to achieve greater than 80% transfection efficiency with several blood cell lines as well as primary T 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 knockout, knock-in, activation, or repression, know that we have a solution for you. For those who are new to CRISPR gene editing, we offer the new TrueDesign Genome Editor, a hands-on workshop and educational resources to help you get started.

artist’s rendition of a DNA double helix

Cell culture

Once the cells have been isolated, they are cultured. Whether working with a patient’s cells (autologous) or donor cells (allogeneic), maintaining the health of the cells is paramount. Our extensive selection of Gibco CTS GMP-manufactured media and reagents are designed specifically for cell therapy manufacturing, including serum-free media and serum replacement. CTS cell culture media and reagents help minimize the risk of contamination and variability in your research and provide extensive traceability documentation including FDA Drug Master Files and Regulatory Support Files to support regulatory review, helping to facilitate a seamless transition from research to commercialization.

artist’s rendition cells and antibodies

Fill and finish

Cell wash, fill, finish and transport are crucial steps of the cell therapy workflow. It is essential to have high-quality reagents for cell wash. After the final product is washed and purified and has received regulatory approval, it 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, Luminex, NGS and others.

scientists in lab

Logistics and clinical trial management

Once fill-finish is complete, 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 maintain the integrity of your materials, from cell collection to delivery to the patient.

Cell and gene therapy solutions for every step

Thermo Fisher Scientific is here to help accelerate the pace of cell and gene therapy development. We offer high-quality solutions for every stage of development, regulatory documentation and support, and access to expert consultation—allowing for a seamless transition from basic research to the clinic and commercialization.

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Intended uses of the products mentioned on the page vary. For specific intended use statements, please refer to the product label.