Recombinant Human GDNF GMP Protein, CF GMP Best Seller
R&D Systems, part of Bio-Techne | Catalog # 212-GMP
Key Product Details
Source
NS0
Accession #
Structure / Form
Disulfide-linked homodimer
Conjugate
Unconjugated
Applications
Binding Activity, Bioactivity
Product Specifications
Source
Mouse myeloma cell line, NS0-derived human GDNF protein
Arg109-Ile211
Manufactured and tested under cGMP guidelines.
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 Kd <1 nM.
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 Kd <1 nM.
Mycoplasma
Negative when tested in a ribosomal RNA hybridization assay.
Host Cell DNA
< 0.015 ng per µg of protein when tested by PCR.
Scientific Data Images for Recombinant Human GDNF GMP Protein, CF
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
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.
|
Background: GDNF
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.
Long Name
Glial Cell line-derived Growth Factor
Alternate Names
ATF, HFB1-GDNF, HGDNF, HSCR3
Gene Symbol
GDNF
UniProt
Additional GDNF Products
Product Documents for Recombinant Human GDNF GMP Protein, CF
Manufacturing Specifications
GMP ProteinsR&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:
- 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 for Recombinant Human GDNF GMP Protein, CF
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.
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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.
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For preclinical, or clinical ex vivo use
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