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GMP Grade Cytokines

GMP Grade Cytokines
Introduction
Immune cell therapy, represented by CAR-T/NK cells has shown significant therapeutic effects in the treatment of various malignant tumors such as leukemia, lymphoma, and multiple myeloma. As more and more immune cell therapies enter the stage of clinical research, quality management systems have attracted more attention from the industry. During the process of immune cell therapy products, cytokines such as IL-15, IL-7, IL-21 are used as a key raw material for T/NK cell activation and amplification. Therefore, safe, effective, and compliant cytokines are crucial for the success of R&D processes and applications of immune cell therapy drugs.
ACROBiosystems is committed to the development of high-quality reagents that are used in the clinical stage of immune cell therapy drugs. Based on the GMP-grade quality management system platform, combined with the production specifications of cell therapy drugs, we have successfully developed a series of high-quality GMP-grade cytokines such as IL-15, IL-7, IL-21. These products are produced with strict quality management and drug-level release testing standards. Our GMP-grade cytokines* can better assist the clinical research of immune cell therapy drugs and accelerate the global regulatory approval of biological products.
* ACROBiosystems GMP grade products are designed for research, manufacturing use, or ex vivo use. CAUTION: Not intended for human in vivo applications.

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ACROBiosystems GMP Quality Management System
Quality Management System

Manufactured and QC tested under GMP compliance

Designed under ISO 9001:2015 and ISO 13485:2016

Animal-Free materials

Materials purchased from approved suppliers

ISO 5 cleanrooms and automatic filling equipment

Qualified and well-trained personnel

Quality-related documents reviewed and approved by QA

Fully batch production and control records

Equipment maintenance and calibration

Validation of analytical procedures

Stability studies conducted

Comprehensive regulatory support files

Click here to applicate the
Regulatory Support File (RSF)
Automatic filling equipment
Automatic filling equipment
Sterilization equipment
terilization equipment
Strict quality standards
(Example for GMP IL-15 release standard)

SDS-PAGE>95%

Endotoxin level less than 10 EU/mg

Residual Host Cell DNA content less than 0.02ng/μg

Residual Host Cell Protein content less than 0.5ng/ug

Biological activity >0.8 x 107 IU/mg (Reference the WHO Human IL-15 (NIBSC code: 90/530) as standard)

Microbial testing

Mycoplasma testing

In vitro virus assay

Batch-to-batch consistency

Comprehensive stability data support (accelerated, freeze-thaw, long-term, shipping stability verification)

Product Features

Strict Quality Control Standards

- 16 quality control standards.

- Excellent safety profile (testing for sterility, mycoplasma, endotoxin, and residual impurities).

- High stability and batch-to-batch consistency.

GMP Grade Quality Management System

- ISO 5 cleanrooms used for filling.

- Raw materials and packing materials are registered.

- Facilities are available for online and on-site audits.

Accelerating Global Regulatory Approval of Biological Products

- A comprehensive set of regulatory documents is available.

- Validation reports for analysis methods are available by request.

- FDA DMF filed

Product List
MoleculeCat. No.Product DescriptionPreorder/Order
IL-15GMP-L15H13GMP Human IL-15

Order

IL-7GMP-L07H24GMP Human IL-7

Order

IL-21GMP-L21H25GMP Human IL-21

Preorder

More GMP Products
MoleculeCat. No.Product DescriptionPreorder/Order
CD3GMP-MC0323GMP Monoclonal Anti-Human CD3 Antibody (OKT3) DMF Filed

Order

BenzNucleaseGMP-NUES19GMP GENIUS™ Nuclease

Preorder

Cas9GMP-CA9S19GMP NLS-Cas9 Nuclease

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Data

High purity

High purity than 90% of GMP Human IL-15

High purity than 90% of GMP Human IL-15  

High bioactivity

BCMA

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).

High stability

Validation of Accelerate and Freeze-thaw stability
GMP-L15H13

GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25℃ for 72 hours and freeze-thaw 3 times without performance reduction.

Long-term stability testing(25℃)
GMP-L15H13

GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25 ℃ for 90 days without performance reduction performance reduction.

High batch-to-batch consistency

GMP-L15H13

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.

TERMS AND CONDITIONS

MANUFACTURING SPECIFICATIONS

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:

  1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.

  2. Animal-Free materials

  3. Materials purchased from the approved suppliers by QA

  4. ISO 5 clean rooms and automatic filling equipment

  5. Qualified personnel

  6. Quality-related documents review and approve by QA

  7. Fully batch production and control records

  8. Equipment maintenance and calibration

  9. Validation of analytical procedures

  10. Stability studies conducted

  11. 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:

  1. SDS-PAGE

  2. Protein content

  3. Endotoxin level

  4. Residual Host Cell DNA content

  5. Residual Host Cell Protein content

  6. Biological activity analysis (Reference the WHO Human IL-15 (NIBSC code: 90/530) as standard)

  7. Microbial testing

  8. Mycoplasma testing

  9. In vitro virus assay

  10. Residual moisture

  11. Batch-to-batch consistency


DISCLAIMER

ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.

TERMS AND CONDITIONS

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.

More CAR-T Related Products

References

  • [1] Libby, Kendra A, and Xiaolei Su. Imaging Chimeric Antigen Receptor (CAR) Activation[J]. Methods in molecular biology. 2020, 153-160.

  • [2] Chinese Pharmacopoeia

  • [3] 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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