FREQUENTLY ASKED QUESTIONS
About Recombinant Albumin
Endotoxins are heat stable toxic components of bacterial cell walls that are created when the bacterium dies. The toxin contained in the cell walls of some microorganisms, especially gram-negative bacteria, produces fever, chills, shock, leukopenia, and a variety of other symptoms result, depending on the particular organism and the condition of the infected person. Very low levels are important for some applications and their relative absence at low level also reflect the use of careful, high quality production, purification and packaging procedures by the manufacturer.
The production specifications for endotoxin for 9801 and 9803 are less than 2 EU/mg, measured values typical less than 0.1 – 0.2 EU/mg. Production specifications for 1101 and 1102 are less than 50 Eu/mg.
9803 safety has been demonstrated in animals with no observed adverse reaction.
Note: While we manufacture ceratin products with endotoxin levels which meet or exceed US FDA guidelines, our albumin is not currently FDA approved for drug or medical device applications.
In many applications recombinant albumins perform as good as or better than the best lots of plasma derived albumin, with superior lot to lot reproducibility.
We are constantly evaluating and improving the long term storage and stability of our products. The shelf life of our sterile 5% products, 9801 and 9803 have been demonstrated to exceed 5 years when stored at 4C.
Traditionally, endotoxin levels for pharmaceutical injection grade serum must be at or below 4EU/mg according to USP 24 standards. Low endotoxin level is important when albumin is used in preclinical studies, as a component in endotoxin sensitive products, such as excipients, cell culture, IVF and in certain medical device applications.
Both XL and Ultra Pure grades are high purity and low endotoxin. Ultra Pure is subjected to several additional purification steps resulting in a highly stable monomeric albumin solution. Because of recent purification improvements, the purity differences are now more visually apparent: Ultra Pure 5% is clear, essentially colorless, while solutions of XL 5% are the characteristic clear, light yellow.
Yes. We perform custom formulation for many of our customers. There is usually a minimum fee for this service. For orders of 5 grams or more, the fees are typically 10%, depending on the materials and procedures involved.
No yeast impurities have been detected by highly sensitive Western Blot analysis.
Yes. Please contact us for your specialized requirements.
Yes. Product 9803, 5% sterile high purity formulation, has been safely administered in rodents using bolus injections up to 25mg/kg with no observed adverse reactions.
No. While many of our products are produced at high purity and have been tested successfully in animals, these products are for research purposes only and are not approved by the FDA for pharmaceutical applications.