Cytokines & Proteins

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