Recently, the GMP-grade recombinant human interleukin-3 (IL-3) protein independently developed by Yeasen Biotech successfully passed the Drug Master File (DMF) filing of the U.S. Food and Drug Administration (FDA), with the filing number: MF042688.
When users choose Yeasen Biotech’s DMF-filed products to advance pharmaceutical R&D projects and submit drug applications to the FDA, they can directly reference the DMF filing number. This serves as a substitute for the detailed information about the raw materials and excipients that would otherwise need to be exhaustively provided during the application process, significantly streamlining the entire review workflow, boosting approval efficiency, and accelerating the pace of drug launch.
What Are GMP-grade Cytokines?
GMP-grade cytokines refer to cytokine products manufactured in full compliance with the Good Manufacturing Practice (GMP) standards. Their core characteristics are “quality control, safety compliance, and suitability for pharmaceutical/medical device R&D and production,” distinguishing them from research-grade cytokines intended solely for laboratory studies.
The core requirements center on “full process compliance in production,” such as production environments meeting cleanroom standards (e.g., Class 10,000 or Class 100 cleanrooms), The production process must include comprehensive process validation, quality control documentation, and traceability systems. The final products undergo rigorous testing for purity, impurities (e.g., endotoxins, microorganisms, adventitious agents), and stability. This ensures consistent quality and safety across every batch, making it suitable for direct use in scenarios directly impacting human health, such as cell therapy, gene therapy, and vaccine production.
Yeasen GMP-Grade Recombinant Human IL-3 Protein
To meet the demands of cell therapy drug development, Yeasen Biotech has developed GMP-grade recombinant human IL-3 and subjected it to comprehensive quality control testing. This ensures strict standards for product purity, activity, safety, and consistency.
1. Product advantages
High purity: > 95%, avoiding immune reactions caused by host cell protein (HCP) or DNA residues.
Ultra-low endotoxin: < 10 EU/mg, reducing the risk of fever or inflammation.
Batch-to-batch consistency: Ensures stability and reproducibility of cell culture.
Compliance: Meets regulatory requirements for cell therapy products and supports IND filing.
Animal-Origin free: Free from animal viruses, pathogenic substances, and adventitious agents contamination, ensuring high safety.
2. Compliance with regulatory guidelines
The production and quality control of GMP grade proteins comply with the following systems and processes:
a) Comply with the "Pharmacopoeia of the People's Republic of China" 2020 edition of the three general rules: quality control of raw materials and excipients for biological products.
b) Comply with USP Chapter <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing.
c) Comply with Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.
3. Quality management system
a) GMP proteins are produced, tested and released under a quality management system certified to ISO 13485:2016 to ensure batch-to-batch consistency and material traceability.
b) With Certificate of Analysis (COA).
c) Animal-origin free materials and production environment.
d) Production base for raw and auxiliary materials for pharmaceutical products.
e) Support online/offline auditing.
4. Product safety quality inspection system
Endotoxin: < 10 EU/mg
Host DNA residue: < 20 ng/mg
Host protein residue: < 0.5 ng/μg
Sterility test: negative
Mycoplasma: negative
Adventitious viruses: negative
5. Product data presentation
Figure 1. GMP-grade Human IL-3 protein on SDS-PAGE: the purity is greater than 95%.
b) High biological activity
Figure 2. The results of cell proliferation stimulation assay of Human TF-1 cells showed that GMP grade Human IL-3 has a specific activity of >1.7 x 10^6 IU/mg.
Figure 3. cell proliferation assay of Human TF-1 cells shows that GMP grade Human IL-3 protein is stable at 37℃ for 48 hours after reconstitution.
Figure 4. Cell activity assay results show that GMP Human IL-3 protein is stable after repeated freezing and thawing for 3 times.
d) High batch-to-batch consistency
Figure 5. GMP Human IL-3 cell activity of different batches remains consistent with high batch-to-batch consistency.
Product Information
|
Name |
Cat.NO. |
Size |
|
Recombinant HumanIL-3 Protein （Research-grade） |
10μg/50μg/100μg/500μg/1mg |