Human FGF basic 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.
Synonym
FGF2, BFGF, FGFB, FGF basic, HBGF-2
Source
Human FGF basic, premium grade (BFF-H4117) is expressed from E. coli cells. It contains AA Pro 143 - Ser 288 (Accession # P09038-4).
Predicted N-terminus: Pro 143
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-FGCH17 is the GMP version of this BFF-H4117. 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
This protein carries no "tag".
The protein has a calculated MW of 16.5 kDa. The protein migrates as 17 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) 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.
>95% as determined by SEC-HPLC.
Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 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:
-20°C to -70°C for 24 months in lyophilized state;
-70°C for 3 months under sterile conditions after reconstitution.
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 before lyophilization. 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.
Background
FGF basic is a member of the FGF family of at least 23 related mitogenic proteins which show 35-60% amino acid conservation. FGF acidic and basic, unlike the other members of the family, lack signal peptides and are apparently secreted by mechanisms other than the classical protein secretion pathway. FGF basic has been isolated from a number of sources, including neural tissue, pituitary, adrenal cortex, corpus luteum, and placenta. This factor contains four cysteine residues, but reduced FGF basic retains full biological activity, indicating that disulfide bonds are not required for this activity. bFGF is a critical component of human embryonic stem cell culture medium; the growth factor is necessary for the cells to remain in an undifferentiated state, although the mechanisms by which it does this are poorly defined. It has been demonstrated to induce gremlin expression which in turn is known to inhibit the induction of differentiation by bone morphogenetic proteins. It is necessary in mouse-feeder cell dependent culture systems, as well as in feeder and serum-free culture systems.
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