GMP Human FGF-7 / KGF Protein (CHO)

Product Details

KGF, also known as FGF-7, is a mesenchymal-derived growth factor belonging to the fibroblast growth factor (FGF) family, primarily known for its potent mitogenic effects on epithelial cells. In stem cell differentiation protocols, KGF signaling is critical for promoting the proliferation and expansion of pancreatic progenitor cells. Furthermore, it plays a key role in the subsequent maturation of these progenitors into endocrine precursors that will give rise to hormone-producing islet cells, including insulin-secreting beta cells.

Product Features and Advantages

1. Specific Endoderm Differentiation Driver​: Efficiently supports stem cell differentiation into definitive endoderm lineages, including pancreatic beta islet cells and other endodermal cell types.
2. Reliable Large-Scale Supply: Ensures consistent batch production capacity exceeding 1 gram, supporting robust scale-up for manufacturing.
3. Stringent Safety Profile​: Incorporates comprehensive virus testing, validation, and ultra-low endotoxin levels (< 0.01 EU/μg) to meet stringent quality standards.
4. Cost-Effective and Convenient​: Achieves up to 50% cost savings versus conventional alternatives, with simplified reconstitution in water instead of hydrochloric acid for ease of use.

GMP Platform Advantages

1. Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
2. End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
3. Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
4. Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
5. Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
6. Professional Support: Extensive manufacturing and application expertise to accelerate development.

Source

GMP Human FGF-7 / KGF Protein (CHO) (GMP-FG7H35) is expressed from CHO cells. It contains AA Cys 32 - Thr 194 (Accession # P21781-1).

Predicted N-terminus: Cys 32

Molecular Characterization

Other Tags and Version Biotin & Other Labeled Version

This protein carries no "tag".

The protein has a calculated MW of 18.9 kDa. The protein migrates as 27 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.

Endotoxin

Less than 10 EU/mg, tested by the rFC method in compliance with USP <86> and Ph. Eur. 2.6.32.

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

Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

Mycoplasma

Negative

Purity

>95% as determined by SDS-PAGE.

Formulation

Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.

Contact us for customized product form or formulation.

Vial Specification

2R (13 mm neck finish)

Shipping

This product is supplied and shipped with blue ice, please inquire the shipping cost.

Storage

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

Please avoid repeated freeze-thaw cycles.

This product is stable after storage at:

1. -20°C to -70°C for 5 years in lyophilized state;
2. -70°C for 12 months under sterile conditions after reconstitution.

ACRO Quality Management System

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

MANUFACTURING SPECIFICATIONS

ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems Quality Management System Contents：

1. GMP-certified facility (compliance with FDA cGMP, EMA GMP, ICH, ISO9001/13485/MDSAP, and certified by third-party SGS, UL, and RX360)
2. Animal origin-free materials, equipments, and facilities
3. Materials sourced only from approved suppliers
4. ISO 5 cleanrooms and automatic filling equipment
5. Professional quality personnel and training programs
6. Validated analytical testing methods in accordance with the ICH guidelines
7. Safety Testing (Sterility, Mycoplasma, etc): compliant with USP, EP, etc
8. In-depth stability studies
9. Fully batch production and control records
10. Equipment maintenance and calibration

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

1. SDS-PAGE
2. Protein content
3. Endotoxin level
4. Residual Host Cell DNA content
5. Residual Host Cell Protein content
6. Biological activity analysis
7. Microbial testing
8. Mycoplasma testing
9. In vitro virus assay
10. Residual moisture
11. Batch-to-batch consistency

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1. PRODUCT USE RESTRICTIONS & PROHIBITIONS

• 1.1 ACROBiosystems ("ACRO") GMP grade products ("Products") are designed for research, manufacturing use or ex vivo use.
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2. REVERSE ENGINEERING PROHIBITED & CONFIDENTIALITY

• 2.1 Purchaser shall not reverse-engineer, decompile, disassemble, sequence, analyze via bioinformatics, or otherwise attempt to discover the structure, sequence, composition, construction, manufacturing process, or any trade secret embodied in the Products. Purchaser shall not permit any third party to undertake such activities.
• 2.2 All specifications, data, and know-how related to the Products provided by ACRO are ACRO's confidential information and shall be protected accordingly.

3. LIMITED WARRANTY & DISCLAIMERS

• 3.1 ACRO warrants solely that Products will conform to their published specifications when used under normal, specified laboratory/manufacturing conditions and within their labeled expiration date. THIS IS THE ONLY WARRANTY PROVIDED.
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  (b) Obtaining any necessary regulatory approvals or intellectual property licenses for Purchaser's use.
  (c) Compliance with all applicable laws, regulations (including but not limited to cGMP/GLP where claimed), and industry standards.
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  (e) Proper storage, handling, and use of Products according to ACRO's instructions.
  
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• IN NO EVENT SHALL ACRO, ITS AFFILIATES, OR SUPPLIERS BE LIABLE FOR ANY OF THE FOLLOWING, HOWSOEVER ARISING (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, STATUTE, OR OTHERWISE):
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5. END USER ACKNOWLEDGEMENT & COMPLIANCE

• 5.1 By accepting, opening, or using the Products, the End User (Purchaser or its downstream recipient) agrees to be irrevocably bound by all terms herein.
• 5.2 End User explicitly acknowledges the Products are NOT FOR HUMAN ADMINISTRATION and agrees not to use them in any in vivo human application, directly or indirectly.
• 5.3 End Users unwilling to accept these terms must immediately: (a) cease all use; (b) notify ACRO or their supplier; and (c) return the unopened, unused Products.
• 5.4 ACRO reserves the right to audit End User's compliance with these restrictions upon reasonable notice.

ACRO has the right, at its sole discretion, to modify, add or remove any terms herein without notice to Purchaser and/or End User. Any changes to these terms are effective immediately following the updating of such changes on ACRO’s website or published specifications or product-related documents.