2L bioprocess container containing closed system media

Manufacture of cell therapies is varied, complex, and expensive. Transitioning from open systems to closed systems reduces the risk of contamination or human error and can increase manufacturing efficiencies, boosting the likelihood of clinical and commercial manufacturing success while also reducing the need for costly Class A clean room use.

To meet this trend in the field and help you scale and close your process, many of our Gibco CTS reagents are now offered in a BioProcess Container format suitable for a closed system workflow.We know that maintaining flexibility throughout your manufacturing workflow is critical in the development process, so we designed our bioprocess containers to be versatile with the option of aseptic integration into your workflow through sterile welding, Luer-Lock connections, or via a universal MPC quick-connect.

Your workflow is worth it; end the expensive, risky, and time-consuming manual transfer of media and reagents from bottles to bags.

Flexible packaging formats suitable for aseptic integration

Flexible and adaptable bioprocess container

The Gibco CTS reagents you trust are now available in a flexible BioProcess Container (BPC) format suitable for connection into closed systems.  

  • Seamless translation—CTS cell culture media and reagents are now available off-the-shelf in closed system–compatible packaging to help reduce lead times as you move to close your process
  • Versatile—incorporate into your closed manufacturing system through the use of female-threaded Luer-Lock connectors, MPC connectors, or sterile welding. The PVC and/or C-Flex tubing sets are compatible with market-leading sterile welding equipment enabling aseptic integration into your cell and gene therapy manufacturing workflow
  • Quality testing and documentation—reagents and single-use technologies comply with industry standards and are backed by regulatory documentation and support (Drug Master File and/or a Regulatory Support File, Certificate of Analysis, and Certificate of Origin)
  • Trusted packaging—the BPC chamber is constructed from Thermo Scientific Aegis5-14 Film, a five-layer cast film manufactured using no animal derived components in a cGMP facility. This film has outstanding physical characteristics and low leachable/extractable profiles to support purity, quality, and integrity of the product filled into the container
     

Bioprocess Container Option 1—Large volume

 Line 1Line 2Line 3
UtilityNot intended for customer use. Fill line used during product manufactureLarger diameter tubing to accommodate faster flow rate applications (e.g., media transfer)Smaller diameter tubing composed of two segments that give customers flexibility
ConnectorsTubing is sealedMPC quick connectSeptum port
OR
Female luer lock
Tubing materialEVA
Ethyl vinyl acetate
C-FlexMedical grade PVC, DEHP free
OR
C-Flex
Welding compatibleNot intended for customer useGeneral sterile welding 
18 inches of C-Flex
Sterile welding 
Rotea compatible
12 inches of PVC 
General sterile welding
12 inches of C-Flex 
 Tubing dimensionsNot intended for customer use  1?4 inch inner diameter 3?32 inch inner diameter 1?8 inch inner diameter
3?32 inch wall thickness
1?32 inch wall thickness
1?16 inch wall thickness

Products available in this format

Gibco CTS AIM V Medium is a fully defined serum-free formulation for proliferation and/or manipulation of T cells, dendritic cells, and other primary or immortalized cells. It contains L-glutamine and is formulated with or without phenol red and antibiotics, making it ideal for research or manufacturing. Gibco CTS AIM-V Medium, without phenol red, without antibiotics, is now accessible with flexibility to sterile weld or aseptically connect to closed systems in a fill volume relevant for autologous and small-scale allogeneic CGT manufacturing.

  • Adherence to supplier-related responsibilities of USP <1043>*
  • Approved for use in multiple clinical trials globally
  • Intuitive design and versatility connection to close your workflow

*Other aspects of USP <1043> will be the responsibility of the end-user to assess. Thermo Fisher Scientific cannot fulfill USP <1043> in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the AM).

Gibco CTS NK-Xpander Medium is an animal origin-free, GMP-manufactured medium designed to proliferate a high yield of functional human NK cells to address the needs of translational and clinical cell therapy researchers? with or without the use of feeder cells. The 5 L BPC can be sterile welded or aseptically connected to closed systems in a fill volume relevant for autologous NK cell therapy manufacturing.

  • Capable of expanding a high yield of functional human NK cells within 14 days without the use of feeder cells
  • Animal origin-free, manufactured under GMP, and designed to help meet regulatory compliance requirements for ancillary materials used in cell and gene therapy manufacturing 
  • Available in bag format for closed system compatibility with reduced risk of contamination

Gibco Cell Therapy Systems CTS DPBS is the classical Dulbecco’s Phosphate Buffered Saline not containing calcium, magnesium, or phenol red. Gibco CTS DPBS, without calcium chloride, without magnesium chloride is now accessible with flexibility to sterile weld or aseptically connect to closed systems in a fill volume relevant for autologous and small-scale allogeneic CGT manufacturing.

  • Provides an environment that maintains the structural and physiological integrity of cells in vitro
  • Chemically defined and animal origin-free materials suitable for use in clinical research studies
  • Intuitive design and versatility connection to close your system workflow

Gibco Cell Therapy Systems CTS DPBS, the classical Dulbecco’s Phosphate Buffered Saline containing calcium and magnesium chloride is now available in both a bottle or a flexible BioProcess Container (BPC) suitable for use with closed-system instruments.

  • A balanced salt buffer that maintains pH and osmotic balance for washing cells or reagent preparation
  • GMP manufactured for use in clinical research studies
  • Versatile BPC design that allows for sterile welding, MPC quick connect, or Luer lock connections to integrate into your closed-system workflow

Bioprocess Container Option 2—Small volume

 Line 1Line 2
UtilityNot intended for customer use
Fill line used during product manufacture
Evacuation line for media transfer
ConnectorsTubing is sealedSeptum port Female luer lock
Tubing materialEVA
Ethyl vinyl acetate
C-Flex 
Welding compatibleNot intended for customer use
General sterile welding
12 inches of C-Flex
Tubing dimensionsNot intended for customer use1?8 inch inner diameter
1?16 inch wall thickness

Products available in this format

Gibco CTS OpTmizer Pro SFM, bag format is a novel serum-free medium (SFM) without phenol red developed for the growth and expansion of human T lymphocytes (e.g., CD4+, CD8+, polyclonal cells, or antigen-specific T cells) used in allogeneic cell therapies. The medium maintains central memory T cells further into expansion, which is well suited for longer workflows (>15 days). The result is a larger population of central memory T cells in a shorter period of time.

  • Maintains central memory T cells further into expansion
  • Supports T-cell activation using Dynabeads magnetic beads, soluble antibodies, and stimulatory antibody-presenting cell protocols 
  • Ideally suited to the production of allogeneic therapies

Gibco CTS GlutaMAX supplement is an animal origin–free (AOF) dipeptide alternative to L-glutamine, with increased stability that improves cell health. CTS GlutaMAX supplement can be used as a direct substitute for L-glutamine at equimolar concentrations in mammalian and stem cell culture with minimal or no adaptation.

  • Minimizes toxic ammonia build-up—unlike L-glutamine, GlutaMAX Supplement does not spontaneously break down to form ammonia. This prevents waste build-up and maintains a fresh supply of L-glutamine during long-term culture
  • Improves growth efficiency and performance of mammalian cell cultures—lower levels of ammonia results in improved cell viability; in addition, culture conditions are more controlled due to the consistent concentration of GlutaMAX supplement that is not possible with L-glutamine
  • Remains stable across a wide range of temperatures—CTS GlutaMAX supplement retains full functionality at room temperature or 2–8°C, for convenient storage and handling

Gibco CTS TrypLE Select Enzyme, is a recombinant enzyme capable of dissociating a wide range of adherent mammalian cells. CTS TrypLE Select Enzyme is derived from microbial fermentation and provides an animal origin–free (AOF) alternative for porcine trypsin.

  • Animal origin–free (AOF)—free of animal-derived components and formulated on dedicated animal origin-free equipment; CTS TrypLE Select Enzyme may minimize the risk of viral contamination in your manufacturing process
  • Room temperature-stable—product remains stable at room temperature or 2–8°C, making storage and handling easy and convenient
  • Easy to use—CTS TrypLE Select Enzyme substitutes directly into existing protocols with no inactivation required, avoiding the need for trypsin inhibitors, such as FBS
     

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