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What Are GMP-grade Recombinant Proteins?
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GMP-grade recombinant proteins meet the stringent Good Manufacturing Practice (GMP) standards. These guidelines ensure that products, such as biological and pharmaceutical products, are consistently produced and controlled according to high-quality standards. The production process includes the selection of high-grade raw materials, tightly controlled manufacturing environments, and comprehensive process validation.
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Why GMP Compliance Matters
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Compliance with GMP ensures that protein products are manufactured to the highest standards of consistency, stability, and purity. This significantly reduces the risk of contamination by viruses, mycoplasma, bacteria, and endotoxins, which is critical for research and therapeutic applications.
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Applications of GMP-grade Proteins
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GMP-grade proteins are essential for many cell and gene therapies, offering batch-to-batch consistency. They are rigorously tested for contaminants and provide the purity required for high-stakes research, making them ideal for use in therapies like CAR-T cell treatments.
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The Role of GMP-grade Recombinant Proteins in CAR-T Therapy
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Cell therapies, including CAR-T, rely on cytokines and growth factors to support the differentiation, expansion, and cell culturing. Difference production systems can lead to variability in protein properties, which is why GMP-grade proteins are preferred to minimize variability and ensure consistent outcomes to meet regulatory standards.
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Figure 1. Cytokines and growth factors play important roles in the generation of CD8+ T
cells and can drive memory cell profiles[1].
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At MedChemExpress, we produce GMP recombinant proteins under strict guidelines to ensure superior quality and consistency. Using premium growth factors and cytokines ensure safety, efficacy, and minimized batch-to-batch variation.
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We offer GMP-grade recombinant proteins with full documentation and traceability, overseen by independent QA teams. Key quality measures include:
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• Biological Activity Validation
• Purity Testing
• Stability Testing
• Endotoxin Testing
• Molecular weight determination by SDS-PAGE
• Residual Host Cell DNA Content Analysis
• Residual Host Cell Protein Content Analysis
• Mycoplasma Testing
• Additional testing as required
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MCE GMP recombinant proteins are suitable for use as raw materials or ancillary reagents in cell culture (expansion, polarization, and differentiation) or other ex vivo bioprocessing applications.
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Featured Products from MedChemExpress
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Product Name
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Description
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GMP EGF Protein, Human
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A potent stimulators of epidermal and epithelial tissues growth, promoting specific fibroblasts proliferation in cell culture.
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GMP TNF-alpha/TNFSF2 Protein, Human
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A potent pro-inflammatory cytokine, essential in immune regulation and inflammation.
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GMP IL-15 Protein, Human
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Regulates immune cells, promotes the proliferation of NK cells, T cells, and B cells, and stimulates cytokine secretion.
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GMP IL-21 Protein, Human
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An immunomodulatory cytokine that promotes the transition from innate to adaptive immunity.
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GMP IFN-gamma Protein, Human (HEK293)
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A dimeric soluble cytokine with antibacterial, antiviral and antitumor activities.
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GMP IL-6 Protein, Human
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A multifunctional cytokine involved in immunity, tissue regeneration, and metabolism.
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GMP IL-2 Protein, Human (solution)
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Produced by activated CD4-positive helper T cells, IL-2 plays an important role in immune response and tolerance.
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Reference:
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[1] Silveira CRF, et al. Front Immunol. 2022;13:947648.
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Products are for research use only and are not intended for human use. We do not sell to patients.
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