Source	Mouse myeloma cell line, NS0-derived human GDNF protein Arg109-Ile211 Manufactured and tested under cGMP guidelines.
Purity	>97%, by SDS-PAGE with silver staining, under reducing conditions.
Endotoxin level	<1.0 EU per 1 μg of the protein by the LAL method.
N-terminal sequence Analysis	Arg₁₀₉-Gly-Gln-Arg-Gly-Lys-Asn-Arg-Gly-(Cys)
Predicted Molecular Mass	11.6 kDa (monomer)
Activity	Measured in a cell proliferation assay using SH‑SY5Y human neuroblastoma cells. The ED₅₀ for this effect is 2-12 ng/mL in the presence of Recombinant Human GFR alpha ‑1/GDNF R alpha ‑1 Fc Chimera (Catalog # 714-GR). The specific activity of recombinant human GDNF is >5.0 x 10⁵ units/mg, which is calibrated against the human GDNF Reference Standard (NIBSC code: 09/266). Measured by its binding ability in a functional ELISA. Immobilized Recombinant Human GFR alpha ‑1/GDNF R alpha ‑1 Fc Chimera (Catalog # 714-GR) at 1 µg/mL can bind Recombinant Human GDNF with an apparent K_d <1 nM.

Recombinant Human GDNF GMP Protein, CF Scientific Data Examples

	Recombinant Human GDNF GMP Protein Bioactivity GMP-grade Recombinant Human GDNF (Catalog # 212-GMP) stimulates proliferation in the SH-SY5Y human neuroblastoma cell line. The ED₅₀ for this effect is 2-12 ng/mL in the presence of Recombinant Human GFRa-1/GDNF Ra-1 Fc Chimera (Catalog # 714-GR).
	Recombinant Human GDNF GMP Protein SDS-PAGE 1 μg/lane of GMP-grade Recombinant Human GDNF (Catalog # 212-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by silver staining, showing bands at 17 kDa and 33 kDa, respectively.

Formulation, Preparation and Storage

Carrier Free

What does CF mean?

CF stands for Carrier Free (CF). We typically add Bovine Serum Albumin (BSA) as a carrier protein to our recombinant proteins. Adding a carrier protein enhances protein stability, increases shelf-life, and allows the recombinant protein to be stored at a more dilute concentration. The carrier free version does not contain BSA.

What formulation is right for me?

In general, we advise purchasing the recombinant protein with BSA for use in cell or tissue culture, or as an ELISA standard. In contrast, the carrier free protein is recommended for applications, in which the presence of BSA could interfere.

212-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in PBS.
Reconstitution	Reconstitute at 100 μg/mL in PBS.
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.

Reconstitution Calculator

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.

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Background: GDNF

Glial Cell Line-derived Neurotrophic Factor (GDNF) is a neurotrophic factor that has been shown to promote the survival of various neuronal subpopulations in both the central as well as the peripheral nervous systems at different stages of their development. Neuronal subpopulations that have been shown to be affected by GDNF include motoneurons, midbrain dopaminergic neurons, Purkinje cells and sympathetic neurons.

Native GDNF, a disulfide-linked homodimeric glycoprotein, is a novel member of the TGF-beta superfamily. Human GDNF cDNA encodes a 211 amino acid residue prepropeptide that is processed to yield a dimeric protein. Mature human GDNF was predicted to contain two 134 amino acid residue subunits. NS0 expressed mature human GDNF lacks 31 residues from the amino-terminus of the predicted sequence. This glycosylated recombinant mature human GDNF still contains the seven conserved Cys residues found in all members of the TGF-beta superfamily and is biologically active. The GDNF sequence contains two potential glycosylation sites and insect cell‑expressed recombinant rat GDNF proteins are glycosylated. Mature rat and human GDNF exhibit approximately 93% amino acid sequence identity and show considerable species cross-reactivity. Cells known to express GDNF include Sertoli cells, type 1 astrocytes, Schwann cells, neurons, pinealocytes and skeletal muscle cells.

Item	Value
Long Name	Glial Cell line-derived Growth Factor
Entrez Gene IDs	2668 (Human); 25453 (Rat)
Alternate Names	ATF, ATF1, ATF2, Astrocyte-derived trophic factor, GDNF, HFB1-GDNF, HGDNF, HSCR3, glial cell derived neurotrophic factor, glial cell line derived neurotrophic factor, glial cell line-derived neurotrophic factor

Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: WHO TRS, No. 822, 1992 Annex 1, Good Manufacturing Practices for Biological Products; USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and USP Chapter 92, Growth Factors and Cytokines Used in Cell Therapy Manufacturing.

R&D Systems' quality focus includes:

Manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
Documented processes and QA control of documentation and process changes
Personnel training programs
Raw material testing and vendor qualification/monitoring
Fully validated equipment, processes and test methods
Equipment calibration schedules using a computerized calibration program
Facility maintenance, safety programs and pest control
Material review process for variances
Monitoring of stability over product shelf-life

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 research. The Certificate of Analysis provided contains the following lot specific information:

N-terminal amino acid analysis, SDS-PAGE analysis, and endotoxin level (as determined by LAL assay) performed on each bulk QC lot, not on individual bottlings of each QC lot
Post-bottling lot-specific bioassay results (compliance with an established range) and results of microbial testing according to USP
Mycoplasma testing by ribosomal RNA hybridization assay

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, 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.

Product Specific Notices

END USER TERMS OF USE OF PRODUCT

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

We suggest you print and retain a copy of these End User Terms of Use of Product for your records.

The End User is aware that R&D Systems, Inc. sells GMP products for preclinical or clinical ex vivo use and not for in vivo use. The End User further agrees, as a condition of the sale of R&D Systems' GMP products that: a) the End User will not use this GMP Product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the Institutional Review Board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.

R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal .

You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

TERMS AND CONDITIONS

The following limitation applies to R&D Systems' warranty and liability for damages: All products are warranted to meet R&D Systems' published specifications when used under normal laboratory conditions.

R&D SYSTEMS DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, R&D SYSTEMS DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN R&D SYSTEMS AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, R&D SYSTEMS' TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO R&D SYSTEMS FOR THE APPLICABLE PRODUCTS. IN NO EVENT WILL R&D SYSTEMS BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

Full details of R&D Systems' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal .

Citations for Recombinant Human GDNF GMP Protein, CF (1)

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Citations are publications that use Bio-Techne products. Selected citations for Recombinant Human GDNF GMP Protein, CF include:

Species: Human
Sample Types: Whole Cells
Applications: Bioassay

J Piao et al. (2021), Preclinical Efficacy and Safety of a Human Embryonic Stem Cell-Derived Midbrain Dopamine Progenitor Product, MSK-DA01 Cell Stem Cell, 28(2):217-229.e7.
PMID: 33545080

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