Recombinant Human BDNF GMP Protein, CF

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

Catalog #	Availability	Size / Price	Qty
BT-BDNF-GMP-025
BT-BDNF-GMP-01M

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Recombinant Human BDNF GMP Protein Bioactivity.

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

Recombinant Human BDNF GMP Protein, CF Summary

BDNF Manufactured in Bio-Techne's new GMP facility
Lot-to-lot consistency
Stringent guidelines for patient safety
Scalability necessary to support successful therapeutics
Learn more about manufacturing in our new GMP facility
Test it in your process! Request a sample of GMP BDNF

Product Specifications

Purity

>97%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 13121 Da ± 50 Da

Endotoxin Level

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

Activity

Measured in a cell proliferation assay using BaF mouse pro-B cells transfected with TrkB. The ED₅₀ for this effect is 0.100-1.00 ng/mL.

The specific activity of Recombinant Human BDNF is >8.0 x 10⁵ units/mg, which is calibrated against the human BDNF WHO Standard (NIBSC code: 96/534).

Source

E. coli-derived human BDNF protein
Arg134 - Arg247, with an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.

Manufactured and tested under cGMP guidelines.

Accession #

P23560.1

N-terminal Sequence
Analysis

Met-Arg134-Arg-Gly-Glu-Leu-Ser-Val-(Cys)-Asp

Predicted Molecular Mass

13.1 kDa

SDS-PAGE

12 kDa, under reducing conditions.

Product Datasheets

BT-BDNF-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-BDNF-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose.
Reconstitution	Reconstitute the 25 μg size at 250 μg/mL in PBS. Reconstitute all other sizes at 500 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.

Scientific Data

Bioactivity

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GMP-grade Recombinant Human BDNF Protein (Catalog # BT-BDNF-GMP) as measured in a cell proliferationassay using BaF mouse pro-B cells transfected with TrkB. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lotconsistency of GMP BDNF.

Bioactivity

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Equivalent bioactivity of GMP (Catalog # BT-BDNFGMP) and Animal-Free (BT-BDNF-AFL) grades of Recombinant Human BDNF asmeasured in a cell proliferation assay using BaF mouse pro-B cells transfected with TrkB (orange and green, respectively).

SDS-PAGE

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2 μg/lane of Recombinant Human BDNF GMP Protein (Catalog # BT-BDNF-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing bands at 12 kDa, under reducing conditions.

Immunofluorescence

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Dopaminergic neurons were successfully differentiated from human iPSCs using Recombinant Human GMP BDNF (Catalog # BT-BDNF-GMP). Neurons show bright co-staining of beta tubulin 3 (TUJ1; green), tyrosine hydroxylase (TH; red), and DAPI (blue) to confirm dopaminergic neuron identity. BDNF successfully supported the derivation and maintenance of dopaminergic neurons.

Reconstitution Calculator

Background: BDNF

Brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family of growth factors that are required for the differentiation and survival of specific neuronal subpopulations in both the central as well as the peripheral nervous system.

BDNF is often utilized as a cell culture supplement to promote neural differentiation in regenerative medicine studies and clinical manufacturing protocols.

The neurotrophin family is comprised of at least four proteins including BDNF, nerve growth factor (NGF), neurotrophin-3 (NT3), and NT4/5. Human BDNF is initially expressed as a proprotein, which is then cleaved to yield a mature protein. Mature BDNF is a non-covalently linked homodimer, with each monomer containing antiparallel beta -strands and a characteristic cystine knot motif. Within the mature domain, human BDNF shares the identical amino acid sequence with mature mouse and rat BDNF.

BDNF is strongly expressed in various regions of the brain, including the hippocampus and cerebellum, and weaker expression has been detected in the thymus, liver, spleen, heart, and lung. BDNF participates in axonal growth and pathfinding and in the modulation of dendritic growth and morphology and in later stages of development regulates synaptic transmission and plasticity and acts as a central modulator of pain. BDNF binds with high affinity and specifically activates the TrkB tyrosine kinase receptor. BDNF signaling via TrkB is essential for adult synaptic plasticity and the formation of memories.

The BDNF signaling pathway utilizes both AKT and ERK pathways to exert its pleiotrophic effects in the central nervous system. Decreased expression of BDNF is seen in many neurological diseases such as Alzheimer's disease, Parkinson's disease, Huntington's disease, and autism. Further, BDNF is proposed as a biomarker for psychiatric disorders such as bipolar disease and depression and has been implicated in posttraumatic stress disorder, phobia, and panic disorder. A single amino acid substitution, Val66Met, has been shown to lead to reduced, activity-dependent BDNF secretion and memory impairment.

Long Name

Brain-derived Neurotrophic Factor

Entrez Gene IDs

627 (Human); 12064 (Mouse); 24225 (Rat)

Alternate Names

Abrineurin; ANON2; BDNF; brain-derived neurotrophic factor; BULN2; MGC34632; Neurotrophin

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