CytoPak GMP Human IL-15 Protein

CytoPak GMP Human IL-15 Protein is packaged in sterile closed containers that can be readily incorporated into ex vivo clinical production processes. The bag utilizes medical grade multilayer film with two weldable options. The outlet weldable tube contains a proximal TPE section (1/8’’ ID x 1/4’’ OD) and a distal PVC section (3/32’’ ID x 5/32’’ OD). The liquid state and closed-system packaging of CytoPak GMP Human IL-15 Protein can be directly welded to GMP media bags resulting in safety and user-friendliness by bypassing the reconstitution step during manufacture.

• Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
• End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
• Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
• Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
• Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
• Professional Support: Extensive manufacturing and application expertise to accelerate development.

Met-Asn-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys-Lys-Ile-Glu-Asp
(Routinely tested)

Less than 1.0 EU/mL, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.

<0.5 ng/µg of protein tested by ELISA.

<0.02 ng/μg of protein tested by qPCR.

Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

Negative

>95% as determined by SDS-PAGE.

Supplied as 0.2 μm filtered solution in PBS, rHSA, pH7.4.

Contact us for customized product form or formulation.

This product is supplied and shipped on dry ice.

Upon receipt, store it immediately at -20°C or lower for long term storage.

Please avoid repeated freeze-thaw cycles.

• Can be stored up to 24 months at -20°C;
• Can be stored up to 2 weeks at 2-8°C.