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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.
This protein carries no "tag".
The protein has a calculated MW of 12.8 kDa. The protein migrates as 13 kDa±3 kDa under reducing (R) condition (SDS-PAGE).
>95% as determined by SDS-PAGE.
Supplied as 0.2 μm filtered solution in PBS, rHSA, pH7.4 with protectants.
Contact us for customized product form or formulation.
This product is supplied and shipped with dry ice, please inquire the shipping cost.
Upon receipt, store it immediately at -20°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.
ACROBiosystems Quality Management System Contents：
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files（RSF）
ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testing
In vitro virus assay
Batch-to-batch consistency
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