Recombinant Human PDGF-BB GMP Protein, CF GMP

Key Product Details

Product Specifications

Formulation, Preparation and Storage

Background: PDGF-BB

Platelet-derived growth factor (PDGF) was discovered as a major mitogenic factor present in serum but absent from plasma. It was found to be secreted from the alpha‑granules of platelets activated during the coagulation of blood to form serum. Subsequent studies have demonstrated that PDGF is not one molecule but three, each a dimeric combination of two distinct but structurally related peptide chains designated A and B. The dimeric isoforms PDGF-AA, AB and BB are differentially expressed in various cell types and their effects are mediated through two distinct receptors, termed alpha and beta. Differences exist in isoform binding to each receptor. In general, PDGF isoforms are potent mitogens for connective tissue cells, including dermal fibroblasts, glial cells, arterial smooth muscle cells and some epithelial and endothelial cells. In addition to its activity as a mitogen, PDGF is chemotactic for fibroblasts, smooth muscle cells, neutrophils and mononuclear cells. Other reported activities for PDGF include stimulation of granule release by neutrophils and monocytes, facilitation of steroid synthesis by Leydig cells, stimulation of neutrophil phagocytosis, inhibition of natural killer (NK) cell activity, stimulation of collagen synthesis, modulation of thrombospondin expression and secretion, stimulation of collagenase activity and secretion, induction of contraction of rat aorta strips in vitro, and transient induction of T cell IL-2 secretion accompanied by a down-regulation of IL-4 and IFN-gamma production, temporary effects that may allow clonal expansion of antigen-activated B and T helper lymphocytes prior to differentiation. PDGF also appears to be ubiquitous in neurons throughout the CNS, where it is suggested to play an important role in neuron survival and regeneration, and in mediation of glial cell proliferation and differentiation.

Additional PDGF-BB Products

• All Products for PDGF-BB
• PDGF-BB ELISA Kits
• PDGF-BB Primary Antibodies
• PDGF-BB Proteins and Enzymes
• PDGF-BB 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
• 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