>GMP Grade Cytokines
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With a portfolio of over 5,000 recombinant proteins and an industry-leading, scale-up ready protein development platform, ACROBiosystems has accumulated over 10 years of experience in developing recombinant proteins. Using this platform, our custom GMP-grade protein services are designed to ensure that our proteins are both structurally designed and validated for cellular therapies manufacturing. We take care to adhere strictly to the GMP guidelines with our comprehensive quality management system and quality controls, providing you with high-quality raw materials without disrupting your development process. Our custom GMP-grade protein service is a one-stop service based on your needs to maximize your therapy’s success. We offer two different developmental processes: converting our non-GMP protein products to GMP or developing a custom GMP-grade protein product from scratch.
High purity than 90% of GMP Human IL-15
GMP Human IL-15 (Cat. No. GMP-L15H13) stimulates the proliferation of CTLL-2 cells. The EC50 for this effect is 1.004 ng/mL, corresponding to a specific activity of > 0.8ⅹ10^7 IU/mg, which is calibrated against human IL- 15 WHO International Standard (NIBSC code: 95/554).
GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25℃ for 72 hours and freeze-thaw 3 times without performance reduction.
GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25 ℃ for 90 days without performance reduction performance reduction.
Bioactivity of three different lots of GMP Human IL-15 (GMP-L15H13) verified by cell-based assay, and the result shows very high batch-to-batch consistency.
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.
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
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
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:
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis (Reference the WHO Human IL-15 (NIBSC code: 90/530) as standard)
In vitro virus assay
ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.
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.
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.
 Libby, Kendra A, and Xiaolei Su. Imaging Chimeric Antigen Receptor (CAR) Activation[J]. Methods in molecular biology. 2020, 153-160.
 Chinese Pharmacopoeia
 Corrected Draft Guidance for Industry: Chemistry, Manufacturing,and Control(CMC) Information for Human Gene Therapy Investigation New Durg Applications(INDs). FDA, CBER, 2018.7.20
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