CellGenix® rh IL-2 Connect Prototype

CellGenix® rh IL-2 | Connect is a ready-to-use liquid IL-2 supplied in a weldable single-use bag designed for closed-system cell therapy manufacturing. Unlike traditional lyophilized cytokines, IL-2 | Connect eliminates reconstitution steps, helping reduce contamination risk, manual handling, clean room usage, and operator time.

• Ready-to-use liquid IL-2 for closed connectivity with no reconstitution required
• The potency of rh IL-2 is min. 90 % of designated activity (5 x105 IU /bag in 5 mL volume)
• The two-part tube line for product removal consists of:
1. One 15 cm (6”) weldable TPE tube (1/8"ID x 1/4" OD)
2. One 15 cm (6”) weldable PVC tube (3/32" ID x 5/32" OD)
3. One female luer lock and plug protected by a dust cap

• Seamless progression from lyophilized IL-2 to liquid IL-2. The buffer formulation except for the addition of recombinant human albumin (Recombumin® Elite) is identical to CellGenix® GMP rh IL-2 (order No 1020-050/1020-1000) before lyophilization.
• Animal component-free formulation for improved consistency and safety
• We provide expert regulatory support from development through post-approval. A Drug Master File (DMF) will be filed at the FDA CBER.
• Sustainable Packaging: Using PFAS-free bags validated for freezing, ensuring long shelf life
Designed to support the expansion and differentiation of CAR-T, TCR-T, Treg, TIL, NK, and CIK cells, CellGenix® rh IL-2 | Connect helps enable robust, scalable GMP cell therapy processes.
The commercial GMP launch will be in Q1 2027.