Recombinant Human GDNF GMP Protein, CF New

Catalog #: BT-GDNF-GMP Datasheet / COA / SDS

Catalog #	Availability	Size / Price	Qty
BT-GDNF-GMP-050
BT-GDNF-GMP-01M

Recombinant Human GDNF GMP Protein Bioactivity.

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Product Details

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Summary Product Datasheets Carrier Free Data Images Reconstitution Calculator Background Related Research Areas

Recombinant Human GDNF GMP Protein, CF Summary

Product Specifications

Purity

>97%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 22225 Da ± 5 Da, N-terminal Met species are also present (22356 ± 5 Da)

Endotoxin Level

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

Activity

Measured in a cell proliferation assay using SH‑SY5Y human neuroblastoma cells. The ED₅₀ for this effect is 0.750-9.00 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).

Source

E. coli-derived human GDNF protein
Gly113 - Ile211 with & without an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.

Manufactured and tested under cGMP guidelines.

N-terminal Sequence
Analysis

Gly113-Lys-Asn-Arg-Gly-(Cys)-Val-Leu-Thr-Ala & Met-Gly113-Lys-Asn-Arg-Gly-(Cys)-Val-Leu-Thr

Structure / Form

Disulfide-linked homodimer

Predicted Molecular Mass

11.3 kDa

SDS-PAGE

8 kDa, under reducing conditions.

Product Datasheets

BT-GDNF-GMP

Product Datasheet

COA

SDS

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.

BT-GDNF-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose.
Reconstitution	Reconstitute at 500 μg/mL in sterile water.
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.

Scientific Data

Bioactivity

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The bioactivity of Recombinant Human GDNF GMP Protein (Catalog # BT-GDNF-GMP) was measured in a cell proliferation assay using the cell proliferation of SH-SY5Y cells. Three independent lots weretested for bioactivity and plotted on the same graph to show lot-to-lot consistency of GMP GDNF protein.

Bioactivity

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Equivalent bioactivity of GMP (Catalog # BT-GDNF-GMP) and Animal-Free (BT-GDNF-AFL) grades of Recombinant HumanGDNF as measured in a cell proliferation assay using the cell proliferation of SH-SY5Y cells (orange and green, respectively).

SDS-PAGE

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2 μg/lane of Recombinant Human GDNF GMP Protein (Catalog # BT-GDNF-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing a band at 8 kDa under reducing conditions.

Reconstitution Calculator

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.

Long Name

Glial Cell line-derived Growth Factor

Entrez Gene IDs

2668 (Human); 25453 (Rat)

Alternate Names

Astrocyte-derived trophic factor; ATF; ATF1; ATF2; GDNF; glial cell derived neurotrophic factor; glial cell line derived neurotrophic factor; glial cell line-derived neurotrophic factor; HFB1-GDNF; HGDNF; HSCR3

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