Today’s cell and gene therapy manufacturers are transforming lives by making better therapies more accessible. As a result, ensuring the safety and availability of these medicines is paramount. We recognize that as a supplier into your process we play a critical role in supporting your need for high-quality products, a stable supply chain and robust risk mitigation strategies.
Providing quality for our customers drives everything we do. We offer a collection of Cell Therapy Systems (CTS) products for cell therapy research and further manufacturing of cell-, gene- and tissue-based products and take every measure to deliver the highest quality products and support you need. Our knowledgeable regional regulatory support teams will help you navigate regulatory processes from research through to commercialization. Experienced cell and gene therapy professionals, technical support teams, and highly specialized scientific teams are available to answer your questions, provide detailed product and protocol consultation, as well as customization services.
Careful selection of materials and thoughtful development decisions early in the process can help ease the transition to a scalable and robust cell production process. Gibco CTS products are designed to help you translate your cell therapy to clinical applications with extensive quality control testing and traceability documentation to facilitate regulatory approval, so you can transition your cell therapy to the clinic with confidence. Our products are backed by our professional regulatory support, a robust supply chain, and ISO 13485-certified, FDA-registered manufacturing facilities. Switching to the required GMP-grade raw materials, such as our CTS products, at an early stage can help prevent the need for additional studies at a later date.
Over 30 years of experience with GMP manufacturing enables us to provide high-quality GMP cell and gene therapy reagents, assays and tools. Our quality management systems at our CTS manufacturing sites are independently certified to either ISO 9001 or ISO 13485 (medical devices). CTS products are manufactured in conformity with cGMP for medical devices and follow USP <1043>, and Ph. EUR 5.2.12. Our strategically located manufacturing facilities enable us to supply the highest-quality products to all of our customers globally and uninterrupted. We host more than 200 customer audits each year to support our customers’ quality assurance efforts.
Where possible, our CTS products are designed to meet the requirements outlined in USP 1043 (ancillary materials for cell, gene, and tissue-engineered products) and Ph. EUR 5.2.12 (raw materials of biological origin for the production of cell-based and gene therapy medicinal products).
Gibco CTS media and reagents undergo extensive QC testing following pharmacopeia test methods where possible. Our routine QC on all CTS reagents includes:
Our biological origin raw material traceability, quality control testing and test method references are detailed on our Certificates of Analysis and Origin. These documents are designed to enable risk assessment of CTS products for use in clinical manufacturing. All CTS products have SDS available.
For biological risk components used within CTS formulations such as recombinant proteins expressed in mammalian cells or human plasma-derived proteins we can provide summaries of viral testing or inactivation procedures within our regulatory documentation.
In an effort to help you maximize the potential of your stem cell research and therapy, and simplify the transition to clinical manufacturing processes, we offer an extensive selection of research use products with complementary CTS formulations.
|T cell||MSC||PSC||NSC||HSC||Research Use Only product||Cell Therapy Systems (CTS) product|
|X||N-2 Supplement (100X)||CTS N-2|
|X||AIM V Medium||CTS AIM V Medium|
|X||AIM V Medium||CTS Optmizer|
|X||Dynabeads CD3/CD28||CTS Dynabeads|
|X||X||X||X||X||DPBS (w/ calcium chloride and magnesium chloride)||CTS DPBS (w/ calcium chloride and magnesium chloride)|
|X||X||X||X||X||DPBS (w/o calcium chloride and magnesium chloride)||CTS DPBS (w/o calcium chloride and magnesium chloride)|
|X||X||X||X||X||GlutaMAX Supplement||CTS GlutaMAX-I Supplement|
|X||KnockOut Serum Replacement||CTS KnockOut SR XenoFree Medium|
|X||KnockOut DMEM||CTS KnockOut DMEM|
|X||X||X||TrypLE Select Enzyme||CTS TrypLE Select Enzyme|
|X||Neurobasal Medium||CTS Neurobasal Medium (1X)|
|X||Neurobasal-A Medium||CTS Neurobasal-A Medium (1X)|
|X||X||X||Synth-a-Freeze Medium||CTS Synth-a-Freeze Medium|
|X||Hibernate-A Medium||CTS Hibernate-A Medium|
|X||Hibernate-E Medium||CTS Hibernate-E Medium|
|X||KnockOut DMEM/F-12||CTS KnockOut DMEM/F-12|
|X||Vitronectin Recombinant Human Protein, Truncated||CTS Recombinant Vitronectin|
|X||Versene Solution||CTS Versene|
|X||RevitaCell Supplement (100X)||CTS RevitaCell Supplement (100X)|
|X||Essential 8 Medium||CTS Essential 8 Medium|
|X||Essential 6 Medium||CTS Essential 6 Medium|
|X||PSC Cryopreservation Kit||CTS PSC Cryopreservation Kit|
|X||CytoTune-iPS 2.0 Sendai Reprogramming Kit||CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit|
|X||LV-MAX Production Medium||CTS LV-MAX Production Medium|
|X||Viral Production Cells||CTS Viral Production Cells|
|X||LV-MAX Transfection Kit||CTS LV-MAX Transfection Kit|
|X||Opti-MEM I Reduced Serum Medium||CTS Opti-MEM I Medium|
Changing raw materials in clinical development often creates significant costs and loss of time and may require clinical comparability studies. Utilizing GMP reagents such as our Cell Therapy Systems products at an early stage can help minimize your raw material risk.
All CTS products come with detailed documentation, performance testing and access to regulatory support. CTS products are intended to see the developer across all clinical phases, including commercialization.
As you move from basic cell therapy research to the clinic, high-quality GMP-grade cell therapy products and proper documentation are essential to getting it right the first time. Cell Therapy Systems (CTS) products provide a proven choice for clinical stem cell therapy and immunotherapy research and manufacturing so you can transition your cell therapy to the clinic with confidence. In addition to providing serum-free, xeno-free and animal origin-free formulations our GMP-grade CTS products have cell and gene therapy specific intended use statements, safety testing, and regulatory documentation. We take these measures to provide quality ancillary materials to help minimize risk, ease the burden on your quality systems, and support your regulatory submission—making CTS the superior choice as you transition from the bench to the clinic.
|Standard attributes||Cell Therapy Systems products*||Research Use Only products**|
|Media and reagents are GMP-manufactured at ISO 13485–certified and FDA-registered sites in accordance with USP <1043> and Ph. EUR 5.2.12.||Yes||Most media|
USP Sterility testing or Bioburden
|Animal origin–free formulations||Most||No|
|Regulatory support, Drug Master File and Regulatory Support File||Yes||No|
|Commercial use rights||Yes||No|
|Traceability documentation (COO, COA, SDS, Product Insert)||Yes||Yes|
|Designed to meet global cell therapy standards||Yes||No|
|Intended use statements for clinical manufacturing||Yes||No|
|*For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products|
**For Research Use Only
Cell Therapy Systems products have been used in over 200 clinical trials to date. Several of our products have been used in commercialized cell or gene therapies in USA and EU including CAR T therapies and immunotherapeutic cancer vaccines. This demonstrates both a customer and regulatory agency acceptance of Thermo Fisher Scientific’s CTS products.
We are committed to enabling the commercialization of cell and gene therapies using Thermo Fisher Scientific’s CTS products by customizing formulations/testing, providing continuity of supply, access to relevant regulatory documentation and commercial use rights under mutually committed relationships.
The benefits to the cell therapy developer are multifold:
For further information regarding how Thermo Fisher Scientific may enable your late stage cell therapy development and commercialization efforts please contact: firstname.lastname@example.org
Do you have a proprietary process that requires special adjustments? We offer full customization options to help meet your unique specifications for any project. Every Gibco performance medium can be fine-tuned to your requirements for successful outcomes. Flexibility is yours in creating your own solution.
Gibco CTS products are specifically designed for use in cell or gene therapy applications. The methods and controls used for manufacturing conform to GMP for medical devices, ISO 13485. In addition, our CTS products comply with the requirements for biological derived raw materials as described in USP <1043> and Ph. EUR 5.2.12.
By collaborating with our clients, we are able to provide solutions that optimize quality, service, and cost while delivering performance results. Our knowledgeable regulatory support team will help you navigate regulatory processes from research through to commercialization. Experienced cell therapy professionals leverage decades of cumulative translational and commercial experience to help answer your questions. Regional technical support teams and highly specialized scientific teams are available to provide detailed product and protocol consultation, as well as customization services.