膜杰作
Star Staining
CytoPak™ GMP Human IL-2 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-2 Protein can be directly welded to GMP media bags resulting in safety and user-friendliness by bypassing the reconstitution step during manufacture.
优势特色（Features）
- Closed System Process
- Minimized Manual Touchpoints
- Ready-to-Use Format
- Enhanced Efficiency
- Weldable Tubing
- Designed under ISO 9001:2015 and ISO 13485:2016
- Manufactured and QC tested under a GMP compliance factory
- Animal-Free materials
- Beta-lactam materials free
- Batch-to-batch consistency
表达区间及表达系统（Source）
CytoPak GMP Human IL-2 Protein (GMP-L02H14GB01) is expressed from E. coli cells. It contains AA Ala 21 - Thr 153 (Accession # P60568-1).
Predicted N-terminus: Met
蛋白结构（Molecular Characterization）
This protein carries no "tag".
The protein has a calculated MW of 15.4 kDa. The protein migrates as 16 kDa±2 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).
内毒素（Endotoxin）
Less than 5.0 EU/mL by the LAL method.
宿主蛋白残留（Host Cell Protein）
<0.5 ng/µg of protein tested by ELISA.
宿主核酸残留（Host Cell DNA）
<0.1 ng/μg of protein tested by qPCR.
无菌（Sterility）
The sterility testing was performed by membrane filtration method described in USP<71> and Ph. Eur. 2.6.1.
支原体（Mycoplasma）
Negative.
纯度（Purity）
>95% as determined by SDS-PAGE.
制剂（Formulation）
Supplied as 0.2 μm filtered solution in phosphate with protectants.
Contact us for customized product form or formulation.
运输（Shipping）
This product is supplied and shipped with dry ice, please inquire the shipping cost.
存储（Storage）
Upon receipt, store it immediately at -70°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
- -70°C for 24 months;
- Can be stored up to 1 month at -20°C;
- Can be stored up to 1 week at 2-8°C.
质量管理控制体系（QMS）
电泳（SDS-PAGE）
CytoPak GMP Human IL-2 Protein on SDS-PAGE under reducing (R) and non-reducing (NR) conditions. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).
活性（Bioactivity）-CELL BASE
CytoPak GMP Human IL-2 Protein (Cat. No.GMP-L02H14GB01) stimulates proliferation of CTLL-2 cells. The specific activity of CytoPak GMP Human IL-2 Protein is ≥1.20 x 10^7 IU/mg, which is calibrated against human Interleukin-2 China National Standard (NIFDC code: 270008) (QC tested). China National Institutes for Food and Drug Control (NIFDC) Standard was prepared and calibrated against human IL-2 WHO International Standard (NIBSC code: 86/500) by NIFDC.
Protocol
稳定性（Stability）
The Cell based assay shows that CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) is stable at 25°C for 65 hours.
The Cell based assay shows that CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) is stable after freezing and thawing 3 times.
MANUFACTURING SPECIFICATIONS
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） Request For DMF
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
DISCLAIMER
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for direct human use.
TERMS AND CONDITIONS
All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.
ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS. IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.
END USER TERMS OF USE OF PRODUCT
The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.
The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.
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背景（Background）
Interleukin-2 (IL-2) is an interleukin, a type of cytokine immune system signaling molecule, which is a leukocytotrophic hormone that is instrumental in the body's natural response to microbial infection and in discriminating between foreign (non-self) and self. IL-2 mediates its effects by binding to IL-2 receptors, which are expressed by lymphocytes, the cells that are responsible for immunity. Mature human IL-2 shares 56% and 66% aa sequence identity with mouse and rat IL-2, respectively. Human and mouse IL-2 exhibit crossspecies activity. The receptor for IL-2 consists of three subunits that are present on the cell surface in varying preformed complexes. IL-2 is also necessary during T cell development in the thymus for the maturation of a unique subset of T cells that are termed regulatory T cells (T-regs). After exiting from the thymus, T-Regs function to prevent other T cells from recognizing and reacting against "self antigens", which could result in "autoimmunity". T-Regs do so by preventing the responding cells from producing IL-2. Thus, IL-2 is required to discriminate between self and non-self, another one of the unique characteristics of the immune system.
