Recombinant Human BDNF GMP Protein, CF GMP Best Seller

Key Product Details

Product Specifications

Formulation, Preparation and Storage

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.

Additional BDNF Products

• All Products for BDNF
• BDNF cDNA Clones
• BDNF ELISA Kits
• BDNF Luminex Assays
• BDNF Lysates
• BDNF Primary Antibodies
• BDNF Proteins and Enzymes
• BDNF Simple Plex

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:

• 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 <71>
• Host Cell Protein testing performed by ELISA
• 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.

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

• All molecular biology procedures use animal-free media and dedicated labware.
• Dedicated fermentors are utilized in committed animal-free areas.
  
  

Purification

• Protein purification columns are animal-free.
• Bulk proteins are filtered using animal-free filters.
• Purified proteins are stored in animal-free containers in a dedicated cold storage room.

Quality Assurance

• Low Endotoxin Level.
• No impairment of biological activity.
• High quality product obtained under stringent conditions.

Please read our complete Animal-Free Statement.