GMP-grade human activin A / INHBA protein for therapeutic use

Activin and inhibin are closely related protein complexes with opposing biological functions. Activin enhances FSH biosynthesis and secretion and plays a role in regulating the menstrual cycle.

Many other functions have been found to be exerted by activin, including roles in cell proliferation, differentiation, apoptosis, metabolism, homeostasis, immune response, wound repair, and endocrine function. Conversely inhibin down regulates FSH synthesis and inhibits FSH secretion.

Activins are nonglycosylated homodimers or heterodimers of various β subunits (βA, βB, βC, and βE in mammals), while Inhibins are heterodimers of a unique α subunit and one of the β subunits. Activin A is a widely expressed homodimer of two βA chains. The βA subunit can also heterodimerize with a βB or βC subunit to form Activin AB and Activin AC, respectively. The 14 kDa mature human βA chain shares 100 % amino acid sequence identity with bovine, feline, mouse, porcine, and rat βA.

Introduction

Features

  • Designed under ISO 9001:2015 and ISO 13485:2016 standards
  • Manufactured and QC tested in a GMP-compliant facility
  • FDA DMF filed
  • Animal-free materials
  • Beta-lactam-free formulation
  • Consistent batch-to-batch quality
  • Stringent quality control testing

Source

GMP Human Activin A Protein (GMP-ACAH37) is expressed in CHO cells. It includes amino acids Gly 311 - Ser 426 (Accession # P08476).

N-terminus prediction: Gly 311

Molecular characterization

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

This protein carries no tag.

It has a calculated molecular weight (MW) of 13.0 kDa. Due to glycosylation, it migrates at 13 kDa ± 3 kDa under reducing (R) conditions in SDS-PAGE, as calibrated against the Star Ribbon Pre-stained Protein Marker.

Endotoxin

Using the LAL method, less than 10 EU/mg.

Host cell protein

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

Host cell DNA

qPCR-tested protein at less than 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.

Purity

>95 %, as SDS-PAGE analysis revealed.

Formulation

Lyophilized in PBS at pH 7.4 with protectants from a 0.22 μm filtered solution.

Shipping

This product is supplied and shipped with blue ice.

Storage

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

Please avoid repeated freeze-thaw cycles.

This product remains stable under the following conditions:

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

ACRO quality management system

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

QC and assay protocol

SDS-PAGE

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

GMP Human Activin A Protein was analyzed by SDS-PAGE under reducing (R) and non-reducing (NR) conditions. The gel was stained with Coomassie Blue, confirming that the protein's purity exceeds 95 %, as assessed using the Star Ribbon Pre-stained Protein Marker.

Bioactivity-Bioactivity CELL BASE

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

GMP Human Activin A Protein (Cat. No. GMP-ACAH37) stimulates Human Activin RⅡ (Luc) HEK293 Reporter Cells. The specific activity of GMP Human Activin A Protein is >5.00 × 102 IU/mg, calibrated against the WHO Reference Reagent Activin A (Human, Recombinant) (NIBSC code: 91/626) (QC tested).

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

Compared to other competing products, GMP Human Activin A Protein (Cat. No. GMP-ACAH37) had a higher level of activity.

Application data

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

GMP Human Activin A Protein (Cat. No. GMP-ACAH37) could successfully stimulate endoderm differentiation through the expression of SOX17 and FOXA2 in FACS and immunofluorescence.

Bioactivity-Stability

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

GMP Human Activin A Protein (Cat. No. GMP-ACAH37) is stable at 37 °C for seven hours, according to the cell-based assay.

GMP-grade human activin A / INHBA protein for therapeutic use

Image Credit: ACROBiosystems

GMP Human Activin A Protein (Cat. No. GMP-ACAH37) is stable after three freezing and thawing cycles, according to the cell-based assay.

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