Recombinant Human Betacellulin GMP Protein, CF

Recombinant Human Betacellulin GMP Protein, CF Summary

• BTC 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 Betacellulin

Product Specifications

Product Datasheets

Carrier Free

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.

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.

Background: Betacellulin/BTC

Betacellulin (BTC) is a new member of the EGF family of cytokines that is comprised of at least ten proteins including EGF, TGF-alpha, amphiregulin, HB-EGF, and the various heregulins. All of these cytokines are synthesized as transmembrane precursors and are characterized by the presence of one or more EGF structural units in their extracellular domain. The soluble forms of these cytokines are released by proteolytic cleavage. BTC, a heparin-binding protein, was originally isolated from the conditioned media of mouse pancreatic beta tumor cells as a 32 kDa glycoprotein composed of 80 amino acid residues. The cDNA encoding human BTC was cloned from a human breast adenocarcinoma cell line (MCF-7) cDNA library. Human and mouse cDNAs encode BTC precursor proteins of 178 and 177 amino acid residues, respectively. At the amino acid sequence level, human BTC precursor protein exhibits 79% identity with that of the mouse BTC precursor. In a mouse cell line transfected with human BTC cDNA, three forms of soluble human BTC have been detected: the glycosylated, intact BTC composed of 80 amino acid residues, a truncated molecule lacking 12 amino acid residues from the amino terminus, and a second truncated molecule lacking 30 amino acid residues from the amino terminus. The biological activities of these BTC forms were shown to be identical. BTC can bind to the EGF receptor and is a potent mitogen for Balb/c 3T3 fibroblasts, retinal pigment epithelial cells and vascular smooth muscle cells.

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

• 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.

Please read our complete Animal-Free Statement

Product Specific Notices

Full terms and conditions of sale can be found online in the Protein Sciences Segment T&Cs at: Terms & Conditions.

Related Research Areas

• EGF Family
• EGF Ligands
• Search Cytokine and Growth Factor Products