Human IL-15 protein with GMP certification

Interleukin 15 (IL-15), also referred to as IL15 or IL-15, is a cytokine that shares structural similarities with IL-2. Like IL-2, IL-15 signals through the IL-2/IL-15 beta chain (CD122) and the common gamma chain (γ-C, CD132). It is primarily secreted by mononuclear phagocytes, among other cells, in response to viral infections.

IL-15 plays a crucial role in the immune system by promoting the proliferation of natural killer (NK) cells—key players in the body's defense against virally infected cells. It also regulates the activation and expansion of T and NK cells. IL-15 provides essential survival signals that help maintain memory T cells without antigens and is also involved in NK cell development.

In rodent lymphocytes, IL-15 prevents apoptosis by inducing BCL2L1/BCL-x(L), an inhibitor of cell death. Furthermore, IL-15 has demonstrated the ability to enhance the anti-tumor immunity of CD8+ T cells in preclinical studies. A Phase I clinical trial, conducted by the National Institutes of Health, is currently enrolling patients to assess the safety, dosing, and anti-tumor efficacy of IL-15 in individuals with metastatic melanoma and renal cell carcinoma (kidney cancer).

Features

  • Designed in accordance with ISO 13485:2016 and ISO 9001:2015
  • Developed and QC-tested in a factory that complies with GMP
  • FDA DMF filed
  • Animal-free materials
  • Beta-lactam materials free
  • Batch-to-batch consistency
  • Extensive quality control procedures
  • No animal-derived peptone or lactose was used in the production process

Source

E. Coli cells express GMP Human IL-15 Protein (GMP-L15H13). AA Asn 49-Ser 162 (Accession # P40933-1) is present in it.

Predicted N-terminus: Met

Molecular characterization

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

There is no "tag" on this protein.

The protein's calculated MW is 12.8 kDa. Under reducing (R) conditions, the protein migrates as 13 kDa±3 kDa (SDS-PAGE).

Endotoxin

The LAL technique yields less than 5.0 EU per vial.

Host cell protein

ELISA-tested protein: less than 0.5 ng/µg.

Host cell DNA

Protein tested using the DNA Fluorescent Staining method: <0.02 ng/μg.

Sterility

The membrane filtration method outlined in CP<1101>, USP<71>, and Eur. Ph. 2.6.1 was used to conduct the sterility test.

Mycoplasma

Negative

In vitro virus assay

Negative

Purity

>95%, according to SDS-PAGE.

Formulation

Obtained by lyophilizing a 0.22 μm filtered solution in a 25 mM His solution at pH 6.2 with protective agents.

Shipping

This product is supplied and shipped with blue ice.

Storage

Store it at -20 °C or lower for long-term storage as soon as it is received.

Avoid repeating the freeze-thaw cycle.

This product is stable after storage at:

  • -20 °C to -70 °C for 5 years in lyophilized state.
  • -70 °C for 12 months under sterile conditions after reconstitution.

ACRO quality management system

  • QMS(ISO, GMP)
  • Quality Advantages
  • Quality Control Process

QC and assay protocol

SDS-PAGE

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

SDS-PAGE of GMP Human IL-15 Protein in reducing (R) conditions. Coomassie Blue staining was applied to the gel. More than 95% of the protein is pure.

Bioactivity-Bioactivity CELL BASE

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

CTLL-2 cell proliferation is stimulated by GMP Human IL-15 Protein (Cat. No. GMP-L15H13). When compared to the human IL-15 WHO International Standard (NIBSC code: 95/554), the specific activity of GMP Human IL-15 is > 8.00ⅹ106 IU/mg (QC tested).

Application data

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

CelThera GMP T Cell Expansion Medium (ACROBiosystems, Cat. No. GMP-CM3101) cultivated human PBMCs for 13 days. The culture included 50 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14), 5 ng/mL GMP Human IL-7 Protein (ACROBiosystems, Cat. No. GMP-L07H24), and 1, 10, or 100 ng/mL GMP Human IL-15 Protein (ACROBiosystems, Cat. No. GMP-L15H13). The outcome demonstrates that Acro's GMP Human IL-15 Protein activity is constant between batches.

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

For 14 days, human PBMCs were cultivated in X-VIVO-15 with 50 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14), 5 ng/mL GMP Human IL-7 Protein (ACROBiosystems, Cat. No. GMP-L07H24), and 1, 10, or 100 ng/mL GMP Human IL-15 Protein (ACROBiosystems, Cat. No. GMP-L15H13). The results reveal that Acro's GMP Human IL-15 Protein activity remains consistent across batches.

Bioactivity-Stability

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

According to the cell-based assay, the GMP Human IL-15 Protein (Cat. No. GMP-L15H13) is stable at 37 °C for 48 hours.

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

In a real-time stability experiment conducted at 4 °C for three months, the cell-based assay demonstrates that GMP Human IL-15 Protein (Cat. No. GMP-L15H13) is stable at that temperature.

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

The GMP Human IL-15 Protein (Cat. No. GMP-L15H13) is stable after three freezing and thawing cycles, according to the cell-based assay.

Human IL-15 protein with GMP certification

Image Credit: ACROBiosystems Inc.

The cell-based assay demonstrates batch-to-batch consistency between Acro's GMP and PG IL-15.

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