ACROBioSystems – GMP Grade Cytokines

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.

Back to Top

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
Automatic filling equipment

Sterilization 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)

Back to Top

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

Back to Top

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.

Related Page: Full list of proteins for cell culture Tokyo Future Style offers

Back to Top

Data

High purity

High purity than 90% of GMP Human IL-15

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.

Back to Top

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

Back to Top

Back to Introduction Page of ACROBioSystems

Please contact us for any inquiries, questions, or information requests.
Tokyo Future Style, Inc.
info@tokyofuturestyle.com
TEL：029-851-9222　FAX：029-851-9220

一覧へ戻る場合はこちらをクリックして下さい。