Human Betacellulin Protein, premium grade

Features and Advantages

1. Seamless Transition from Preclinical to Clinical: Same cell clone, process, and QC as GMP products.
2. Enhanced Production Standards: AOF raw materials, pharma-grade excipients, Grade B+A (ISO 5) environment.
3. Comprehensive Quality Control: Additional strict testing for process impurities, sterility, and mycoplasma.
4. Cost-Effective Solution: GMP-comparable quality at an economical price for early development.
5. Risk Mitigation: Enhanced safety through rigorous impurity control and comprehensive testing.

Synonyms

betacellulin, BTC

Source

Human Betacellulin Protein, premium grade (BEN-H5116) is expressed from E. coli cells. It contains AA Asp 32 - Gln 118 (Accession # P35070-1).

Predicted N-terminus: Met

It is produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage.
GMP-BENH15 is the GMP version of this BEN-H5116. These two proteins display indistinguishable performance profiles, thereby ensuring a seamless transition for end users from early preclinical stage to later clinical phases.

Molecular Characterization

Other Tags and Version Biotin & Other Labeled Version

This protein carries no "tag".

The protein has a calculated MW of 9.9 kDa. The protein migrates as 14 kDa±3 kDa under reducing (R) condition, and 14 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under non-reducing (NR) condition (SDS-PAGE).

Endotoxin

Less than 0.01 EU per μg by the LAL method / rFC method.

Host Cell Protein

<0.5 ng/µg of protein tested by ELISA.

Host Cell DNA

<0.02 ng/μg of protein tested by qPCR.

Sterility

Negative

Mycoplasma

Negative

Purity

>95% as determined by SDS-PAGE.

Formulation

Lyophilized from 0.22 μm filtered solution in 20 mM Citric acid, pH2.2 with trehalose as protectant.

Contact us for customized product form or formulation.

Reconstitution

Please see Certificate of Analysis for specific instructions.

For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.

Storage

For long term storage, the product should be stored at lyophilized state at -20°C or lower.

Please avoid repeated freeze-thaw cycles.

This product is stable after storage at:

1. -20°C to -70°C for 24 months in lyophilized state;
2. -70°C for 3 months under sterile conditions after reconstitution.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process

Quality Description

ACRO's Research-grade products are suitable for a wide range of cell culture applications, particularly for research use in academic institutions. These products are sterilized by filtration, followed by lyophilization where applicable. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. Biological activity is calibrated against WHO/NIBSC standards when available.
ACRO's Premium-grade (Pre-GMP) products are characterized by their high quality and enhanced safety profiles, making them ideal for early-stage discovery and manufacturing processes in cell therapy companies. A key advantage is their seamless transition to corresponding GMP-grade versions. Biological activity is calibrated against WHO/NIBSC standards when available. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. In addition, rigorous testing is conducted to ensure the absence of mycoplasma, HCD, and HCP, thereby guaranteeing product safety.