Therapeutic-grade GMP human IL-10 protein

This gene encodes a cytokine primarily produced by monocytes with lower lymphocyte expression. It plays a key role in immunoregulation and inflammation by suppressing Th1 cytokine expression, downregulating MHC class II antigens and costimulatory molecules on macrophages, and promoting B cell survival, proliferation, and antibody production. It also inhibits NF-kappa B activity and participates in JAK-STAT signaling regulation. Mouse knockout studies highlight its critical role in maintaining immune balance in the intestinal tract. Mutations in this gene have been linked to increased susceptibility to HIV-1 infection and rheumatoid arthritis. [RefSeq, May 2020]

Features

  • Developed in accordance with ISO 9001:2015 and ISO 13485:2016 standards
  • Produced and quality control (QC) tested in a GMP-compliant facility
  • Composed of animal-free materials
  • Free from beta-lactam components
  • Ensures batch-to-batch consistency
  • Undergoes rigorous quality control testing

Source

GMP Human IL-10 Protein (GMP-L10H25) is derived from human 293 cells (HEK293). It includes amino acids (AA) Ser 19 to Asn 178 (Accession # P22301).

Predicted N-terminus: Ser 19

Molecular characterization

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

This protein is ‘tag’-free

The calculated MW is 18.6 kDa. When analyzed under reducing conditions (SDS-PAGE) and compared to the Star Ribbon Pre-stained Protein Marker, the protein migrates as 17 kDa ± 3 kDa.

Endotoxin

Contains less than 10 EU/mg as determined by the LAL method.

Host cell protein

Less than 0.5 ng/µg of protein, as tested by ELISA.

Host cell DNA

Less than 0.02 ng/μg of protein, as determined by qPCR.

Sterility

Sterility testing was conducted using the membrane filtration method, following CP<1101>, USP<71>, and Eur. Ph. 2.6.1 guidelines.

Mycoplasma

Negative.

Purity

Greater than 95% purity, as confirmed by SDS-PAGE.

Formulation

  • Lyophilized from a 0.22 μm filtered solution in PBS, pH 7.4, with added protectants.
  • Custom product forms or formulations are available upon request.

Shipping

Supplied and shipped with blue ice.

Storage

Upon receipt, store immediately at -20 °C or lower for long-term preservation.

Avoid repeated freeze-thaw cycles.

Stability:

  • Lyophilized state: Stable for 5 years at -20 °C to -70 °C.
  • After reconstitution under sterile conditions: Stable for 12 months at -70 °C.

ACRO quality management system

  • QMS (ISO, GMP)
  • Quality Advantages
  • Comprehensive quality control processes ensure product reliability.

QC and assay protocol

SDS-PAGE

SDS-PAGE analysis of GMP Human IL-10 Protein in both reducing (R) and non-reducing (NR) conditions. Coomassie Blue was used to stain the gel. According to Star Ribbon Pre-stained Protein Marker, the protein's purity is higher than 95%.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

Bioactivity-Bioactivity CELL BASE

GMP Human IL-10 Protein (Cat. No. GMP-L10H25) prevents RAW264.7 cells from secreting IL-6. The WHO Reference Reagent Interleukin-10 (Human, rDNA derived) (NIBSC code: 93/722) is used to calibrate the specific activity of GMP Human IL-10 Protein, which is > 1.00 x 107 IU/mg (QC tested).

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

Compared to other competing products, GMP Human IL-10 (Cat. No. GMP-L10H25) had a higher level of activity.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

Bioactivity-Stability

According to the cell-based assay, GMP Human IL-10 (Cat. No. GMP-L10H25) is stable at 37 °C for 24 hours.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

The GMP Human IL-10 Protein (Cat. No. GMP-L10H25) is stable at 4 °C for 180 days, according to the cell-based assay.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

Following three cycles of freezing and thawing, the cell-based assay demonstrates that GMP Human IL-10 (Cat. No. GMP-L10H25) remains stable.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

The cell-based assay demonstrates batch-to-batch consistency between Acro's GMP and PG IL-10.

Therapeutic-grade GMP human IL-10 protein

Image Credit: ACROBiosystems Inc

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