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CLINICAL GRADE PRECISION

Recombinant
Human FGF-2

High quality recombinant growth factor for defined media and cell therapy manufacturing.

GMP Manufacturing

✓ Animal-origin-free recombinant production

✓ Carrier-free and tag-free formulation

✓ Animal-origin-free recombinant production

✓ Strict endotoxin control (<0.05 EU/μg)

✓ Consistent batch-to-batch performance

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Recombinant Human FGF-2 protein vial by Canvax
Recombinant human Fibroblast Growth Factor-2 (FGF-2), also known as basic FGF (bFGF), is a potent mitogenic growth factor that regulates cellular proliferation, survival and differentiation in multiple cell types. Through activation of fibroblast growth factor receptors (FGFR1–4), FGF-2 plays a central role in maintaining pluripotency and supporting expansion of stem and progenitor cell populations.

Molecular Architecture

Canvax recombinant human FGF-2 (145 aa) corresponds to the core structured region of the protein sufficient for full biological activity. The protein is produced recombinantly in E. coli under animal-origin-free conditions and supplied carrier-free and tag-free to ensure minimal interference with downstream signaling pathways. This formulation enables convenient storage and reliable reconstitution for use as a controlled raw material in defined cell culture systems and advanced media formulations.

Product Specification

Parameter Specification
Product Human FGF-2 (154aa)
Bioactivity ED50 ≤ 0.1ng/mL
Expression system E. coli
Purity Expression system
Carrier None

Applications in advanced cell culture

Designed for advanced cell culture workflows requiring controlled activation of FGFR signaling.

Stem cell maintenance and expansion (ESCs, iPSCs)

MSC expansion

Organoids & 3D Culture

Serum-free media systems

Applications in advanced cell culture

Bioactivity assay for Recombinant Human FGF-2 145

Recombinant human FGF-2 is designed to support consistent and reliable cell response in demanding culture systems.

Through activation of FGFR signaling pathways, it promotes controlled cell proliferation while preserving key cellular characteristics, making it suitable for stem-cell expansion and maintenance workflows.

The product shows reproducible biological activity and consistent performance across batches, supported by high purity (≥98%) and low endotoxin levels (<0.05 EU/µg).

It is developed to integrate reliably into established processes, maintaining performance under relevant working conditions.

Biological activity is assessed using a cell-based luciferase reporter assay, measuring activation of FGFR-dependent signaling pathways.

Dose-response analysis confirms consistent potency across relevant concentration ranges, with an EC50 within the expected range.

Additional data, including benchmark comparison, stability assessment and extended characterization, are available as part of the full technical documentation.

Download documentation

Quality and GMP Specifications

Canvax operates ISO13485 & GMP-certified facilities designed for the manufacture of biopharmaceutical products in compliance with EU GMP guidelines. Manufacturing and quality systems ensure controlled processes, traceability and consistent product performance.

Canvax supports customer qualification processes, including audits of facilities and quality systems when required.

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Product Specification

Parameter Typical specification
Identity Correct molecular mass
Protein integrity Monomeric FGF-2 protein
Purity >98%
Endotoxin <0.05 EU/μg
Bioactivity EC50 within expected range
Sterility No microbial growth detected
Mycoplasma Negative
Mass spectrometry Single species with expected molecular mass
Residual host cell protein <10 ng/μg
Residual host cell DNA <10 ng/μg
N-terminal sequence analysis Consistent with expected sequence

Why Choose Canvax GMP Products?

GMP-Certified Manufacturing Facilities

Manufacturing of biopharmaceutical products in GMP-certified facilities, supported by established quality systems and aligned with EU GMP guidelines and ISO 13485 standards.

Analytical Characterization

Comprehensive analytical capabilities covering identity, purity and bioactivity, supporting consistent product performance and robust quality control.

Scalable Supply

Scalable manufacturing from development to GMP production, supported by industrial bioprocess capabilities to ensure reliable supply as demand grows.

GMP-Certified Manufacturing Facilities

Manufacturing of biopharmaceutical products in GMP-certified facilities, supported by established quality systems and aligned with EU GMP guidelines and ISO 13485 standards.

Animal-Origin Free Manufacturing

Animal origin-free production is controlled from raw materials to final product, reducing variability and minimizing the risk of contamination, supporting consistent performance in sensitive applications.

Fill & Finish and Packaging

Fill & finish capabilities under controlled conditions, including adaptable formats aligned with customer workflow and packaging requirements.

Canvax supports customer qualification processes, including facility and quality system audits when required.
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Why Choose Canvax GMP Products?

✓ Manufactured in GMP-certified facilities

✓ Consistent batch-to-batch performance

✓ Flexible formats to match customer workflows

✓ Full batch traceability and documentation

✓ Scalable production aligned with clinical demand

✓ Regulatory-ready documentation for FDA and EMA submissions

FAQs

When is GMP-grade FGF-2 required in cell therapy workflows?
GMP-grade FGF-2 is typically required when moving from research or early development into preclinical, clinical or commercial manufacturing stages, where materials must be produced under controlled and traceable conditions.
Why is GMP manufacturing important for growth factors?
GMP manufacturing ensures controlled production, batch traceability and consistent product quality, reducing variability and supporting regulatory expectations in advanced therapy workflows.
What risks are associated with using non-GMP FGF-2 in advanced processes?
Non-GMP materials may introduce variability, limited traceability and regulatory challenges, which can impact process consistency and complicate later-stage development or technology transfer.

Synonyms

View synonyms in all languages

English
Recombinant human FGF-2, GMP FGF-2, fibroblast growth factor 2, basic fibroblast growth factor (bFGF), recombinant bFGF

Spanish
FGF-2 recombinante, factor de crecimiento de fibroblastos 2, bFGF

French
FGF-2 recombinant, facteur de croissance des fibroblastes 2, bFGF

German
Rekombinantes FGF-2, Fibroblasten-Wachstumsfaktor 2, bFGF

Italian
FGF-2 ricombinante, fattore di crescita dei fibroblasti 2, bFGF

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Get in touch with our team to review your application, resolve any remaining questions and receive detailed information, including pricing and supply options.

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