Recombinant Protein Quality – Protein Production

Recombinant protein quality control person at an instrument – protein manufacturing.

Quality is our number one priority. We manufacture more than 95% of our proteins at our facility. This means we have complete control over all quality testing and nothing becomes a product that does not meet our industry-leading specifications. A highly trained technical service staff and the scientists responsible for protein development are on site to answer any questions you might have. R&D Systems’ experience and dedication to protein development and manufacturing is unmatched in the life science industry.

The Road to Research Success

This infographic shows how Bio-Techne products, and our consistency to quality, will help you advance your research efforts. What tools are you using in your research? Good results are everything. Trust your reagents

Download now

Lot-to-Lot Consistency: Ensuring experiments can always be repeated!

  • For new proteins multiple lots are created, all with matching specifications. This ensures that there will be no problem matching original lots in the future.
  • Each new lot is tested side-by-side with previous lots for purity, biological potency, and endotoxin level.

Biological Activity

  • Proprietary methods for accurate protein folding ensure biologically relevant proteins
  • R&D systems uses over 900 validated bioassays to evaluate recombinant proteins bioactivity
  • Bioactivity is measured experimentally with the appropriate biological system.

Endotoxin Level and Microbial Bioburden Test

  • Each new production lot of protein is assessed for endotoxin using the Limulus Amoebocyte Lysates (LAL) assay. The endotoxin specification is an industry-leading <0.1 EU/ug.
  • Each protein is tested to rule out microbial contamination using direct plating and broth dilution, according to guidelines from the United States Pharmacopeia (USP).

Protein Sequence Accuracy

  • N-terminal amino acid sequence analysis is performed for each recombinant protein to verify the protein produced matches the sequence expected

Formulation

  • Recombinant proteins are formulated for best stability and are lyophilized from a sterile filtered solution. They are available without or with a carrier protein, usually bovine serum albumin (BSA) at 50 mg/mg of protein.
  • Recombinant enzymes are in solution and ready to use