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Recombinant Human TGF-beta 3 GMP Protein, CF

Name: Recombinant Human TGF-beta 3 GMP Protein, CF
Brand: R&D Systems
SKU: BT-TGFB3-GMP

R&D Systems | Catalog # BT-TGFB3-GMP

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Product Documents

Product Specifications
Scientific Data
Preparation & Storage
Calculators
Background
Product Documents
Manufacturing Specifications
Specific Notices
Research Areas

Key Product Details

Lot-to-lot consistency
Stringent guidelines for patient safety
Scalability necessary to support successful therapeutics
Test it in your process! Request a sample of GMP TGFB3
Preclinical option available BT-TGFB3-AFL

Source

E. coli

Accession Number

P10600.1

Applications

Bioactivity

View all TGF-beta 3 Proteins and Enzymes »

Product Specifications

Source

E. coli-derived human TGF-beta 3 protein
Ala301 - Ser412
Produced using non-animal reagents in an animal-free laboratory.Manufactured and tested under cGMP guidelines.

Purity

>97%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 25411 Da ± 5 Da.

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Ala301-Leu-Asp-Thr-Asn-Tyr-(Cys)-Phe-Arg-Asn

Predicted Molecular Mass

13 kDa (monomer)

SDS-PAGE

10 kDa, under reducing conditions.

Activity

Measured by its ability to inhibit the IL-4-dependent proliferation of HT‑2 mouse T cells. Tsang, M. et al. (1995) Cytokine 7:389.
The ED₅₀ for this effect is 7.50-75.0 pg/mL.

The specific activity of Recombinant Human TGF-beta 3 is >1.9 x 10⁷ IU/mg, which is calibrated against the Human TGF-beta 3 WHO International Standard (NIBSC code: 09/234).

Host Cell Protein

<0.500 ng per μg of protein when tested by ELISA.

Mycoplasma

Negative for Mycoplasma.

Host Cell DNA

<0.00150 ng per µg of protein when tested by PCR.

Scientific Data Images for Recombinant Human TGF-beta 3 GMP Protein, CF

Recombinant Human TGF‑beta 3GMP Protein Bioactivity.

The bioactivity of Recombinant Human TGF‑beta 3 GMP Protein (Catalog #BT-TGFB3-GMP) was measured by its ability to inhibitthe IL-4-dependent proliferation ofHT‑2 mouse T cells. Three independent lots weretested for bioactivity and plotted onthe same graph to show lot-to-lotconsistency of GMP TGF‑beta 3protein.

Equivalent Bioactivity of GMP and Animal-Free gradesof Recombinant Human TGF-beta 3.

Equivalent bioactivity of GMP (Catalog # BT-TGFB3-GMP) and Animal-Free (BT-TGFB3-AFL) grades ofRecombinant Human TGF-beta 3 as measured by its ability to inhibit the IL-4-dependent proliferation ofHT‑2 mouse T cells (orange and green, respectively).

Recombinant Human TGF‑beta 3 GMP Protein SDS-PAGE.

2 μg/lane of Recombinant Human TGF‑beta 3 GMP Protein (Catalog # BT-TGFB3-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 10 kDa, under reducing conditions.

Formulation, Preparation, and Storage

BT-TGFB3-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in Acetonitrile and TFA with Trehalose.
Reconstitution	Reconstitute at 500 μg/mL in 4 mM HCl.
Shipping	The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage	Use a manual defrost freezer and avoid repeated freeze-thaw cycles. A minimum of 12 months when stored at ≤ -20 °C as supplied. Refer to lot specific COA for the Use by Date. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 3 months, ≤ -20 °C under sterile conditions after reconstitution.

Calculators

The reconstitution calculator allows you to quickly calculate the volume of a reagent to reconstitute your vial. Simply enter the mass of reagent and the target concentration and the calculator will determine the rest.

Volume (to add to vial)

Mass (in vial)

Desired Reconstitution Concentration

Background: TGF-beta 3

TGF beta 3 (transforming growth factor-beta 3) is a member of a TGF-beta superfamily subgroup that is defined by their structural and functional similarities (1-5). TGF-beta 3 and its closely related proteins, TGF-beta 1 and -beta 2, act as cellular switches to regulate immune function, cell proliferation, and epithelial-mesenchymal transition (4, 6, 7). The non-redundant biological effects of TGF-beta 3 include involvement in palatogenesis, chondrogenesis, and pulmonary development (1, 2, 7-9). Human TGF- beta 3 cDNA encodes a 412 amino acid (aa) precursor that contains a 20 aa signal peptide and a 392 aa proprotein. The proprotein is processed by a furinlike convertase to generate a 220 aa latencyassociated peptide (LAP) and a 112 aa mature TGF-beta 3 (10, 11). Mature human TGF-beta 3 shows 100%, 99%, and 98% aa identity with mouse/dog/horse, rat, and pig TGF- beta 3, respectively. TGF-beta 3 is secreted as a complex with LAP. This latent form of TGF-beta 3 becomes active upon cleavage by plasmin, matrix metalloproteases, thrombospondin-1, and a subset of integrins (12). TGF-beta 3 binds with high affinity to TGF-beta RII, a type II serine/threonine kinase receptor. This receptor then phosphorylates and activates type I serine/threonine kinase receptors, TGF- beta RI or ALK-1, to modulate transcription through Smad phosphorylation (13-15). The divergent biological effects exerted by individual TGF-beta isoforms is dependent upon the recruitment of co-receptors (TGF- beta RIII and endoglin) and the subsequent initiation of Smad-dependent or -independent signaling pathways (14, 16, 17).

References

Barrio, M.C. et al. (2014) Cells Tissues Organs. [Epub ahead of print; PMID 24861080].
Doetschman, T. et al. (2012) Genesis 50:59.
Mittl, P.R. et al. (1996) Protein Sci. 5:1261.
Sporn, M.B. (2006) Cytokine Growth Factor Rev. 17:3.
Wahl, S.M. et al. (2006) Immunol. Rev. 213:213.
Chang, H. et al. (2002) Endocr. Rev. 23:787.
Dunker, N. and K. Krieglstein (2000) Eur. J. Biochem. 267:6982.
Jin, J.Z. et al. (2014) Dev. Dyn. [Epub ahead of print; PMID 25104574].
Tang, Q.O. et al. (2009) Expert Opin. Biol Ther. 9:689.
Derynck, R. et al. (1988) EMBO J. 7:3737.
Miyazono, K. et al. (1988) J. Biol. Chem. 263:6407.
Oklu, R. and R. Hesketh (2000) Biochem. J. 352 Pt 3:601.
Cui, X.M. and C.F. Shuler (2000) Int. J. Dev. Biol. 44:397.
de Caestecker, M. (2004) Cytokine Growth Factor Rev. 15:1.
Nakajima, A. et al. (2007) Dev. Dyn. 236:791.
Iwata, J. et al. (2012) J. Clin. Invest. 122:873.
Gatza, C.E. et al. (2010) Cell. Signal. 22:1163.

Long Name

Transforming Growth Factor beta 3

Alternate Names

ARVD1, LDS5, RNHF, TGFB3, TGFbeta 3

Entrez Gene IDs

7043 (Human); 21809 (Mouse); 25717 (Rat)

Gene Symbol

TGFB3

UniProt

P10600.1

Additional TGF-beta 3 Products

Product Documents for Recombinant Human TGF-beta 3 GMP Protein, CF

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Certificate of Analysis

To download a Certificate of Analysis, please enter a lot or batch number in the search box below.

Note: Certificate of Analysis not available for kit components.

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Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

R&D Systems' quality focus includes:

Designed, manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
Documented and controlled manufacturing process
Control of documentation and process changes by QA
Personnel training programs
Raw material inspection and vendor qualification/monitoring program
Validated equipment, processes and test methods
Equipment calibration and maintenance schedules using a Regulatory Asset Manager
Facility/Utilities maintenance, contamination controls, safety and pest control programs
Material review process for variances
Robust product stability program following relevant ICH guidelines

R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their application. Each product is provided with a lot-specific Certificate of Analysis that contains the product's specifications and test results. Quality control testing may include, but is not limited to:

N-terminal amino acid analysis
SDS-PAGE purity analysis
Molecular weight analysis via mass spectrometry
Endotoxin assessment per USP <85> and Ph. Eur. 2.6.14 guidelines
Bioassay analysis
Microbial testing per USP <71> and Ph. Eur. 2.6.1 guidelines
Host cell protein assessment
Host cell DNA assessment
Mycoplasma assessment

Additional testing and documentation requested by the customer can be arranged at an additional cost.

Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis and St. Paul, Minnesota USA.

R&D Systems sells GMP grade products for preclinical or clinical ex vivo use. They are not for in vivo use. Please read the following End User Terms prior to using this product.

Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

Production