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 from 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
This webinar will cover regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support to enable successful clinical translation.
In this application note you will learn about Thermo Fisher Scientific’s digitally compatible, GMP-compliant, semiautomated manufacturing platform, which when used with Gibco CTS reagents, protocols, and analytics can result in consistent, efficacious CAR T cell production.
Learn how the new state-of-the-art cell therapy manufacturing and collaboration center on University of California, San Francisco Mission Bay campus will empower researchers to scale future clinical campaigns.
Improved T Cell Function Through Metabolic Modulation Towards an Early-Memory Status Webinar
Improved cell therapy performance through automated cell processing and metabolically modulated cellular products.
Watch one patient’s story of receiving cell therapy treatment
When his lymphoma grew faster than expected, Paul Chae was treated with CAR-T cell therapy at Massachusetts General Hospital. This therapy represents a significant step forward in developing immunotherapies—therapies that use a patient’s own immune system to combat their disease. Paul is now cancer-free thanks to this innovative technology.
A cell therapy journey from vein to vein
Realize your vision of transforming cells into life-saving cell therapies.
Current and future state of T cell therapy manufacturing—Closing, automating and preparing for the T cell therapy revolution
This webinar features updates from industry leaders on the current status of their research in the T cell therapy manufacturing space and the challenges associated with supporting conversion of autologous to allogeneic workflows.
Decentralized manufacturing: Enabling scalable and cost-effective point of care for cell and gene therapies
Standardization via automation and introduction of quality control via closed system manufacturing will contribute to overcoming barriers in cell and gene therapy manufacturing. Tune in to this webinar to hear from experts as they discuss the evolution of the industry and where it's headed.
It’s imperative that successful viral manufacturing pipelines deliver a consistent, pure, and high-titer product that exhibits good safety and efficacy in order to meet regulatory requirements. During this symposium session, our presenters will highlight upstream and downstream solutions across the AAV production workflows.
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.
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.
As cell therapy applications continue to advance, so do the possibilities for improved health outcomes. Download our infographic to learn more about the history and future of cell therapy.
Advances in gene therapy research are showing signs of success with reduced toxicity, increased accuracy in subjects, and less invasive delivery with fewer potential side effects compared to traditional drugs or surgery. Download our infographic to learn more.
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
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: 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
- 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.
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Learn about our solutions to help you achieve your cell therapy goals from research to commercialization
Services and Support
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Cell & Gene Therapy cGMP Manufacturing Services
Contact our experienced team for cell and gene therapy cGMP manufacturing services
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.