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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.

GMP Grade Cytokines

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

Automatic filling equipment
Automatic filling equipment
Sterilization equipment
terilization equipment

GMP Grade Cytokines

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)

GMP Grade Cytokines

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
GMP Grade Products Residue Detection Kits

GMP Grade Cytokines

Custom GMP-grade Protein Services

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.

GMP Grade Cytokines

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.

Request your GMP Protein Sample

What GMP proteins (50µg samples, lyophilized) would you like to try?
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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

ACRO Quality

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