What is cell and gene therapy?

According to the Bio-Process Systems Alliance, “Cell therapy is defined as the administration of cells to a patient to treat disease.” Cell and gene theory manufacturing begins by collecting cells, isolating them, modifying the genes, expanding the cells, and harvesting them. Next, you finish or fill them in, then freeze or store the cells until you are ready to infuse the patient to treat the disease. There are two types of cell therapy: autologous cell therapy, which uses a patient’s own cells, or allogenic cell therapy, which uses a donor cell and treats multiple patients. Both these types of CGT (cell gene therapy) have strict requirements for sterility, extractables, biocompatibility, and particulate levels. Furthermore, cell gene therapies cannot be sterilized through filtration.

Single-use technology for Cell gene Therapy

Single-use technology in CGT manufacturing helps ensure these requirements are met. For example, single-use technologies support sterility before the package is opened and eliminate the need to clean components. To meet applicable requirements, it is important to understand the regulatory standards used to evaluate single-use technologies. The United States Pharmacopeia (USP) evaluates SUTs for biocompatibility and particulates through established standards. For example, USP <87> tests the cytotoxicity of polymeric materials. USP <88> evaluates the biological response of animals to different types of polymeric materials. USP <661> helps ensure the safety of health-related products packaged in plastic containers. It is important to recognize the standards applicable to cell and gene therapy and confirm that your supplier has met them. In CGT every drop of substance matters because of the cost of the substance and the small volume you are using. Therefore, it is important to ensure your supplier has a leak-proof connection system that reduces hold-up volume, minimizing your costs.

What is the EZCellGene™ Single-Use Bottle Assembly?

The EZCellGene™ Single-Use Bottle Assembly is engineered for sterile small-volume fluid transfer in cell and gene therapies. It features small-bore 1/16” x 3/16” tubing. Available in sizes from 30 mL to 2 L and two different bottle types: Titanium Round bottles and EZBio® bottles. You can also choose from three different connecter types depending on what is suited to your needs. For example, the polypropylene plug is used to keep inner tubing free of contaminants before use. The polypropylene Luer lock connects small-diameter tubing with secure, leak-proof connections. Lastly, the MicroCNX connector is designed for small-volume sterile transfers.

How does EZCellGene™ meet the requirements of cell gene therapy?

The EZCellGene™ is suited to the requirements of cell gene therapy in several ways. Some features of the design lend themselves to CGT. In CGT, every small volume matters. Therefore, a leak-proof design is necessary. The tubing uses an over-molded silicone design that integrates the tubing directly into the cap to ensure a leak-free performance. Furthermore, the small-bore tubing allows controlled, gentle flow that protects fragile cells such as IPSCs, stem cells, and CAR-T cells. There is a V-notch dip tube at one end of the tubing for near-complete fluid extraction, which reduces hold-up volume. In addition, the titanium round bottles meet some of the USP specifications. They meet the standards for USP <85>, <87>, <88>, <661>, <665>, <778>, and <891>. All the features are engineered with the applications of cell gene therapy in mind.