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 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)
     

Bioprocess Container Option 1—Large volume

  Line 1 Line 2 Line 3
Utility Not intended for customer use. Fill line used during product manufacture Larger diameter tubing to accommodate faster flow rate applications (e.g., media transfer) Smaller diameter tubing composed of two segments that give customers flexibility
Connectors Tubing is sealed MPC quick connect Septum port
OR
Female luer lock
Tubing material EVA
Ethyl vinyl acetate
C-Flex Medical grade PVC, DEHP free
OR
C-Flex
Welding compatible Not intended for customer use General sterile welding 
18 inches of C-Flex
Sterile welding 
Rotea compatible
12 inches of PVC 
General sterile welding
12 inches of C-Flex 
 Tubing dimensions Not 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 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

Bioprocess Container Option 2—Small volume

  Line 1 Line 2
Utility Not intended for customer use
Fill line used during product manufacture
Evacuation line for media transfer
Connectors Tubing is sealed Septum port  Female luer lock
Tubing material EVA
Ethyl vinyl acetate
C-Flex 
Welding compatible Not intended for customer use
General sterile welding
12 inches of C-Flex
Tubing dimensions Not intended for customer use 1⁄8 inch inner diameter
1⁄16 inch wall thickness

Products available in this format

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

CTS TrypLE Select, is a recombinant enzyme capable of dissociating a wide range of adherent mammalian cells. CTS TrypLE Select 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 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 substitutes directly into existing protocols with no inactivation required, avoiding the need for trypsin inhibitors, such as FBS
     

Resources

Support