What is cell and gene therapy?
During cellular replication, if genes become mutated or duplicated, an opportunity for disease can be created. By using cells and genes as therapeutic agents, it is possible to deliver durable cures. Instead of more traditional approaches such as small molecules and biologics that treat symptoms, these "living drugs" can persist in the patient for many years or potentially a lifetime. "Cell and gene therapy" is a single approach to addressing disease, but the potential methods for delivering treatments differ. This complex technology is quickly evolving and facing multiple challenges; quality and safety are paramount, and time is precious. Cell and gene therapies offer hope for many, as they are enhancing and saving the lives of people who often have no other treatment option.
Cell therapy utilizes living cells form the patient or a donor to replace damaged or diseased cells or to stimulate the body’s immune response or regeneration. Usually stem cells and immune cells are used, and a typical method involves removing the cells from the body, repairing or editing the error in the gene, and then returning the cells to the body. When cells undergo gene editing outside of the body and then returned to the body, this is referred to ex vivo gene therapy.
Gene therapy treats diseases with genetic material to change or supplement a gene whose absence or abnormality is causing the disease. Treatments can happen outside the body (ex vivo) or inside the body (in vivo).
As you move your stem cell, immunotherapy or gene therapy research toward the clinic, your product selection, lab process, documentation, and quality assurance steps become more demanding. This collection of resources will help you gain a better understanding of cell and gene therapy research, feel confident at every step, and maximize your time, effort, and clinical outcomes.
Cell and gene therapy features
Enabling hope for cancer patients through CAR-T cell therapy and Dynabeads technology
Nicole Gularte was diagnosed with acute lymphoblastic leukemia. After participating in multiple clinical trials, she qualified for a new clinical trial utilizing CAR-T cell therapy, which uses Thermo Fisher’s Gibco CTS Dynabeads technology.
In this interview with Calley Hirsch, CCRM, we learn about the critical importance of scalable viral vector manufacture to support the commercial-scale production of CAR-T therapies.
New viral and non-viral platforms for T-cell engineering
In this webinar, we will highlight the different viral and non-viral delivery approaches used in T cell engineering for cell and gene therapy applications including LV-MAX Lentiviral Production System and novel gene editing tools for primary T cells.
GMP ancillary materials for cell and gene therapy manufacturing: what to consider and when to switch
This webinar covers regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support. Considerations for scalability, consistency of supply and commercial use rights to help you to commercial manufacturing.
CTS Mini-documentary series
Hear expert perspectives on recent trends facing the cell therapy industry.
Regardless of where you are in your cell therapy development, we have solutions to help you achieve your cell therapy goals—all the way through to commercialization.
Cell & gene therapy subtopics
With the recent surge of cellular T cell–based immunotherapies, more and more researchers are taking an interest in these specialized immune cells, particularly with respect to the development of chimeric antigen receptor T cell (CAR-T) therapies.
- App note: CTS OpTmizer T-Cell Expansion SFM, No Phenol Red, Displays T-Cell Manufacturing Workflow Flexibility
- App note: The Benefits of Supplementing CTS OpTmizer T-Cell Expansion SFM, No Phenol Red
- Article: Ex Vivo Expansion of Human T Cells for Adoptive Immunotherapy using the Novel Xeno-Free CTS Immune Cell Serum Replacement
- Brochure: Empowering Technologies for Immuno-Oncology Research
- Interview: Enabling Cell & Gene Therapy Raw Materials Standardization and Regulatory Compliance
Stem cell therapy
Stem cell therapy utilizes the power of stem cells to repair or replace damaged cells to restore normal function and treat a variety of diseases.
- App note: Manufacturing Pluripotent Cell Therapeutics White Paper
- Brochure: Mesenchymal Stem Cell Sourcebook
- Handbook: Pluripotent Stem Cell Resource Handbook
- Poster: A Sendai Viral Reprogramming Kit for Completely Xeno-Free Generation of iPSC
- Webinar: GMP Cell Banks as part of a Staged, Standardized, Platform-Style Cell Production Process
- Webinar: CTS StemPro HSC Expansion Medium for Cell and Gene Therapies
The increased interest in gene therapy has led to the need for more cost-effective and viral vector manufacturing platforms. Viral vector gene therapy is now widely used because of its involvement in advanced clinical trials and regulatory approved therapies in combination with technological improvements in characterization and safety profiling.
Adeno-associated viral vectors
- Article: Overcoming downstream purification challenges for viral vector manufacturing: enabling advancement of gene therapies in the clinic
- Article: Upstream and Downstream solutions for AAV manufacturing
- Poster: Streamlined high performance extraction and quantitation of host cell residual DNA
- Brochure: Lentiviral Vector Production
- Interview: Addressing the Challenges of Commercial-Scale Manufacture of Viral Vectors for CAR-T Therapies
- Poster: Large Scale Serum Free Suspension Lentiviral Production System for Gene Therapy Application
- Webinar: New Viral And Non-Viral Platforms for T Cell Engineering
Contract development manufacturing services
Scaling up to commercialization
As a world leader in serving science, the innovative solutions from Thermo Fisher Scientific are designed to help accelerate the development of gene-modified cell therapies and gene therapies. With solutions that span the entire workflow, we offer superior products, services, and expertise to help companies develop breakthrough gene therapies.
- App note: Cell and Gene Therapy Kit Production
- App note: Orbital Shakers
- Blog: Fisher Clinical Services Insights Blog
- Brochure: Advanced Therapy Clinical Development and Commercialization
- Brochure: Cell Therapy Solutions for Every Step: Streamline the Path from Discovery to Cure
- Case study: Reducing Cost within Advanced Therapy Clinical Trials
- eBook: Cell Therapy Logistics
- Infographic: Smarter Protection Never Takes a Day Off: Thermo Scientific Herasafe 2030I Biological Safety Cabinets
- Online resource: Brammer Bio
- Online resource: CTS Support
- Online resource: Fisher Clinical Services Learning Center
- Related service: Biologics Management
- Related service: Cold Chain Management and Expertise
- Related service: Fisher Clinical Services: Cell and Gene Therapy
- Related service: Qualification/Validation Services
- Webinar: Driving Productivity in Cell & Gene Therapy Supply Chains
- Webinar: GMP Ancillary Materials for Cell and Gene Therapy
- Webinar: Transportation Solutions for Cell & Gene Therapy
Cell therapy products
To help maximize the potential of your research and simplify the transition to clinical manufacturing processes, we offer an extensive selection of high-quality research use reagents and Cell Therapy Systems products that are specifically designed for cell therapy research applications. We are here to meet your needs with high-quality products intended for cell and gene therapy research. In addition to media and reagents, we offer cell engineering solutions, purification, characterization, QC testing, services, and equipment.
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.