ACROBioSystems – GMP Grade Cytokines|Tokyo Future Style, Inc.

Intoduction

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, ACROBiosystems 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. ACROBiosystems’s 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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GMP QMS

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

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)

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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

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Product List

GMP Grade Products		Residue Detection Kits
Cat. No.	Product Name	Cat. No.	Product Name
GMP-CA9S18	GMP GENPower™ NLS-Cas9 Nuclease	–	This residue detection kit is still under development.
GMP-DL4H23	GMP Biotinylated Human DLL4 Protein, His,Avitag™	–	This residue detection kit is still under development.
GMP-DL4H28	GMP Human DLL4 Protein, Fc Tag	–	This residue detection kit is still under development.
GMP-FGCH17	GMP Human FGF basic Protein	–	This residue detection kit is still under development.
GMP-FLLH28	GMP Human Flt-3 Ligand Protein	–	This residue detection kit is still under development.
GMP-IFGH24	GMP Human IFN-gamma Protein	–	This residue detection kit is still under development.
GMP-ILBH16	GMP Human IL-1 beta Protein	–	This residue detection kit is still under development.
GMP-L02H14	GMP Human IL-2 Protein	CRS-A003	resDetect™ Human Interleukin-2 (IL-2) ELISA Kit (Residue Testing)
GMP-L04H26	GMP Human IL-4 Protein	CRS-A004	resDetect™ Human Interleukin-4 (IL-4) ELISA Kit (Residue Testing)
GMP-L06H27	GMP Human IL-6 Protein	CRS-A005	resDetect™ Human Interleukin-6 (IL-6) ELISA Kit (Residue Testing)
GMP-L07H24	GMP Human IL-7 Protein	CRS-A025	resDetect™ Human Interleukin-7 (IL-7) ELISA Kit (Residue Testing)
GMP-L15H13	GMP Human IL-15 Protein	CRS-A024	resDetect™ Human Interleukin-15 (IL-15) ELISA Kit (Residue Testing)
GMP-L21H25	GMP Human IL-21 Protein	CRS-A010	resDetect™ Human Interleukin-21 (IL-21) ELISA Kit (Residue Testing)
GMP-MBS001	GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads	–	This residue detection kit is still under development.
GMP-MC0323	GMP Monoclonal Anti-Human CD3 Antibody (OKT3)	CRS-A015	resDetect™ Anti-CD3 Antibody ELISA Kit
GMP-MC2824	GMP Monoclonal Anti-Human CD28 Antibody	CRS-A014	resDetect™ Anti-CD28 Antibody ELISA Kit
GMP-NUES19	GMP GENIUS™Nuclease	CRS-A016	resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing)
GMP-SCFH25	GMP Human SCF Protein	–	This residue detection kit is still under development.
GMP-TNAH23	GMP Human TNF-alpha Protein	–	This residue detection kit is still under development.
GMP-VC1H25	GMP Human VCAM-1 Protein, Fc Tag	–	This residue detection kit is still under development.
GMP-VE5H23	GMP Human VEGF165 Protein	–	This residue detection kit is still under development.

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Data

High purity

High bioactivity

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 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 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

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.

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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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