Product Safety & Stability
Endotoxin released from gram-negative bacteria is a widespread cause of contamination of medical products. Therefore, it’s crucial to perform an endotoxin test on the sterile product, medical device or pharmaceutical product which is to be injected or implanted into the patient’s body, to confirm that no endotoxin has been carried over through the manufacturing process from any starting materials.
Advaxia uses a quantitative endpoint LAL chromogenic test to quantify the endotoxin level in adenovirus preparations. We begin by mixing samples with the LAL reagent and chromogenic substrate reagent over a short incubation period, then read the resulting sample on a spectrophotometer or plate reader which is capable of measuring 405-410 nm. A standard curve is created using the E. coli endotoxin standard included with each kit to calculate endotoxin levels as low as 0.1 EU/mL, where one endotoxin unit/mL (EU/mL) equals approximately 0.1ng endotoxin/mL of solution.
As a result, we arrive at a precise quantitative reading of the product’s endotoxin level, and its purity from contamination, prior to its release.
In addition, we have implemented a rapid quantitative bacterial endotoxin test assay.
The Endosafe® nexgen-PTS™ is a rapid point of use test system which provides quantitative chromogenic test results in less than 15 minutes. The technology utilizes licensed LAL reagents in a disposable cartridge using the nexgen-PTS™ for a completely contained, real-time endotoxin assay. This enables us to test a quantity of samples in a very fast timeframe and with high sensitivity, quantitative results.
The purpose of stability testing is to provide evidence on how the quality of product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and containers, and to establish a re-test period for the product or a shelf life and recommended storage conditions.
Advaxia performs rigorous stability testing on all viral vector products we manufacture and assesses each product according to ICH guidelines.
In addition to the standard stability studies, we also test viruses under stressed conditions, and by running in-use stability testing. We also offer pre-formulation studies, which can help further identify the ideal matrix for a virus product.