iLiteTM alphabeta
Neutekbio's iLiteTM alphabeta kit is a simple and rapid test for the detection and quantification of the biological activity of Type I human IFNs. The test provides qualitative and quantitative measurements of all Type I IFNs including IFNα, IFNβ and IFNω. The test can efficiently measure IFN activity in serum, cerebrospinal fluid, urine, cell culture media and fermentation broths.
The iLiteTM alphabeta test can detect as little as 0.8 IU of IFNα bioactivity per ml of sample. The limit of detection for IFNβ is 6.0 IU per ml of sample. The effective measurement range (i.e., linear dose response) is from 1.5 IU per ml to approximately 200 IU per ml of sample. Both of these assay parameters are dependent upon length of incubation time.
Potential clinical and research laboratory applications include:
Clinical Studies
New forms of the IFNs are now in clinical development and the existing, approved forms are being tested for new disease indications. Performance evaluation studies have demonstrated that the iLiteTM technology can accurately measure IFN bioactivity in blood, and cerebral spinal fluid. The test can be validated and used in drug registration studies and drug approval submissions.
Clinical Research
Abnormal levels of IFN have been implicated in numerous diseases including systemic lupus erythematosis, insulin-dependent diabetes mellitus, autoimmune haemolytic anaemia, myasthenia gravis, thyroiditus, uveitis and Bechet's Disease.
Because of the absence of a fast and reliable bioassay for the Type I IFNs, the corroboration and extension of these clinical findings into diagnostic tools has been impossible. A reliable and repeatable IFN bioassay is now available to verify and validate these potentially important diagnostic results.
Monitoring Production Yields
The Type I IFNs used therapeutically have been produced using bacterial fermentation, animal cell culture, and plant tissue culture. The composition of the growth media vary significantly can be complex and contain factors which interfere with precise IFN measurement.
Although ELISA assays are useful in the estimation of protein mass, the results provide no information regarding bioactivity. The iLiteTM technology can be employed to complement current bioprocess monitoring assays, is easy and amenable to process validation studies.
Product Recovery and Purification
The initial form of IFN in a recombinant DNA based production process can be either inactive inclusion bodies or active, secreted protein. The ability to rapidly determine protein mass and bioactivity is critical in demonstrating manufacturing control of recovery and purification procedures. It is important to note that when dealing with high levels of IFN activity (e.g., >25 IU per ml of buffer) the assay can be completed within 4-6 hours.