Cell Therapy Systems Support

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.

Designed to meet raw and/or starting material needs for cell and gene therapy manufacturing

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.

Ancillary materials manufactured according to GMP

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.

Quality control

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:

• Sterility (for aseptic products only) or Bioburden Testing
• Mycoplasma
• Performance testing based on the intended use
• Real time stability with meaningful stability indicating tests

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.

(Top)

Cell Therapy Systems products with complementary research use reagents allow a more seamless transition from research to clinical applications

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.

Designed to help transition from research use to clinical and commercial scale

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.

Advantages of CTS products as compared to our research use reagents

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.

Proven use in cell therapies

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.

Enabling commercial use and supply assurance

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:

• Supply assurance to provide comfort that your drug will have access to Thermo Fisher Scientific’s products at a defined specification and “on time and in full” when required
• Regulatory support beyond Phase 1 support of our products to ensure successful regional approvals
• Commercial use rights  extending beyond any applicable Limited Use Label Licenses  that are conveyed with the catalog product

For further information regarding how Thermo Fisher Scientific may enable your late stage cell therapy development and commercialization efforts please contact: outlicensing@thermofisher.com

(Top)

Product standards aligned with global regulatory guidance

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.

Experienced cell therapy professionals

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.

Traceability documentation

• Extensive traceability documentation including FDA Drug Master Files (DMF) and Regulatory Support Files (RSF), certificates of analysis (COA), and certificates of origin (COO) ease the burden on your quality systems by helping to support your regulatory submission and reduce risk throughout. Prior to requesting a DMF or RSF, please email cellculturesupport@thermofisher.com to request a COA and COO.
• Request a COA or COO
• Request a DMF
• Request a RSF

Media definitions

• Ancillary material (AM)—material that comes into contact with the cell or tissue product during cell processing, but is not intended to be part of the final product formulation. An AM can also be described as a raw material.
• Animal origin–free—free of animal components in the direct formulation (primary level)
• Chemically defined component—substance whose chemical structure is identified/known at a molecular level. Highly purified recombinant proteins are included.
• Excipient—material that is present in the cellular therapeutic product administered to the patient (other than the active substance).
• Starting materials—the materials from which the active substance is manufactured or extracted.
• Xeno-free—may contain ingredients, components, or subcomponents of human origin but does not contain animal derived components.
• Serum-free—no human or animal serum is used, but the product may still contain individual serum proteins like transferrin and/or human serum albumin. These materials are not animal origin–free but are less biologically variable and/or there is no need to add additional serum to the mix.

(Top)