GMP Recombinant Human TGF-β3 Protein is widely used in biological labs, especially in regenerative biology, biomaterial development, tissue reprogramming, and signaling pathway research. This article focuses on its technical characteristics, production under Good Manufacturing Practice (GMP) conditions, and its roles in experimental design, without making claims related to health, safety, or human application. All references come from recognized public educational and scientific institutions to support transparency, reliability, and proper research validation.
What Is TGF-β3?
Transforming Growth Factor Beta 3 (TGF-β3) is a multifunctional signaling molecule. It belongs to the TGF-beta superfamily, which includes over 30 different proteins involved in developmental signaling, extracellular matrix remodeling, and transcription regulation.
According to NCBI Gene, the TGFB3 gene encodes a secreted ligand that plays essential roles in tissue development and cell fate determination.
In controlled in vitro systems, TGF-β3 supports mesodermal and ectodermal lineage specification, particularly during early patterning and cartilage formation, as discussed in PubMed Central.
GMP Manufacturing Standards
Producing TGF-β3 under GMP conditions ensures reproducibility and quality. These processes align with standards outlined by the U.S. Food and Drug Administration (FDA) and guidance in Code of Federal Regulations Title 21 (ecfr.gov).
Manufacturing under GMP includes:
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Endotoxin control per FDA LAL Guidelines
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Sterile filtration and aseptic processing
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Batch documentation and audit traceability
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Protein identity and purity analysis, often done via SDS-PAGE and HPLC
For an overview of current GMP principles, refer to the FDA’s cGMP resource page.
Biochemical Properties of TGF-β3
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Molecular weight: ~25 kDa (monomeric), but active as a dimer
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Source: Expressed in E. coli or mammalian cells
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Storage: Typically stored at -20°C in lyophilized or liquid form
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Carrier options: Carrier-free or stabilized with BSA or HSA
Stability profiles follow standards found in USP General Chapters and ICH Q5C for biotechnological product stability.
Mechanism of Action
TGF-β3 interacts with TGF-beta receptors type I and II, initiating SMAD2/3 phosphorylation. This signaling cascade impacts gene transcription associated with matrix formation, cytoskeletal reorganization, and signal crosstalk with MAPK, PI3K, and WNT pathways.
Further information about this signaling pathway is detailed in NCBI Bookshelf and the National Library of Medicine.
Applications in Research
1. Chondrogenic Differentiation
TGF-β3 is part of induction cocktails for turning mesenchymal progenitor cells into cartilage-like tissue. Lab protocols from University of Washington and NIH-funded studies validate this application.
2. Extracellular Matrix Studies
It enhances the production of collagen type II and aggrecan, as shown in matrix production studies archived on PubMed.
3. Neural Patterning
When added to ectodermal lineage cultures, TGF-β3 modulates neuronal subtype specification, based on work at University of California, San Francisco and summarized in NIH RePORTER.
4. Wound Healing Models
In non-animal wound healing models, TGF-β3 is used to study scarless healing and fibroblast plasticity, as described in research projects indexed by NLM.
5. 3D Bioprinting Support
GMP TGF-β3 is integrated into bioinks for 3D printing protocols in tissue mimicry, referenced by labs like MIT’s Institute for Medical Engineering and Science.
Quality Control & Testing
Testing of GMP Recombinant Human TGF-β3 typically includes:
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Endotoxin Assay – validated using LAL chromogenic methods as outlined by FDA guidance
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SDS-PAGE and Western Blot – for protein identity and integrity
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Mass Spectrometry – used in labs such as Proteomics Core Facility, Harvard
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Activity Assay – e.g., SMAD-responsive luciferase reporter systems
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Sterility Testing – guided by USP <71>
All assays are validated per the NIH’s assay validation principles.
Comparison with Non-GMP Grade
| Feature | GMP Grade | Research Grade |
|---|---|---|
| Production | Validated under GMP | No GMP validation |
| Sterility | Aseptic processing | Non-sterile |
| Documentation | Full batch records | None |
| Endotoxin Testing | < 0.1 EU/µg | Variable |
| Application Suitability | Translational protocols | Exploratory experiments |
Guidance on grade selection is found in academic documents from University of Michigan and UCLA.
Packaging and Storage
GMP TGF-β3 is typically:
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Supplied lyophilized at 1 µg to 100 µg per vial
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Stored at ≤ -20°C (short-term at 4°C after reconstitution)
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Resuspended in 4 mM HCl with 0.1% BSA
Formulation is described in FDA Biologics Licensing Review, and CDC’s Laboratory Biosafety Manual provides handling practices.
Ethical Sourcing and Regulatory Oversight
All GMP TGF-β3 products must be produced using non-animal-derived raw materials or materials documented under traceability frameworks as specified in:
In academic settings, sourcing transparency aligns with guidelines from:
Conclusion
GMP Recombinant Human TGF-β3 Protein is a highly controlled, extensively characterized tool for in vitro biological research. It is ideal for developmental biology, matrix regulation, signaling studies, and differentiation protocols. With validated production pathways, tight quality controls, and clear regulatory frameworks from .gov and .edu sources, it stands as a core component in many advanced biological research pipelines.
For additional resources: