PHILADELPHIA — PBL InterferonSource and Neutekbio plan to jointly develop and market what they have dubbed “ready-to-go” cell-based assay kits based on Neutekbio’s proprietary iLite technology, which is designed to detect and quantify cytokine activity.
Terms of the deal, signed in April, call for PBL to provide interferons and other cytokines to Neutekbio, which will develop an assay that can detect and measure the activity in the cells.
The alliance is noteworthy because the kit would significantly reduce the time required to perform these types of interferon activity assays, allowing scientists to expand their research capacity, said Ronald Jubin, PBL’s R&D manager. The assay format eliminates the need for continuous cell culture, preparation of viral stocks, and the subjective assessment of cytopathology.
Several weeks ago, Neutekbio began selling an iLite human IFN-alpha kit in North America. The kit combines cryopreserved reporter cells with growth-arrested cells. If type-1 interferon is added to these cells, the result is a dose-dependent production of luciferase.
Piscataway, NJ-based PBL, which supplied the interferons, is among the world’s largest producers of interferons and related products for the life sciences research market
The assays, which are manufactured according to ISO 13485 certification guidelines, take one day to run, according to Jubin. First, a series of dilutions are prepared using IFN stock provided in the kit. Then, 25 μL of cell suspension is added to a 96-well plate, followed by 50 μL of assay diluent.
Finally, 25 μL of the IFN standards [negative and positive controls] are added to each well, the plate is incubated at 37° Celsius for eight to 18 hours, after which time, 100 μL of lysis substrate are added to each well and the plate is read on a luminometer five to 30 minutes later, said Jubin. The assays could potentially be run on 384- or 1,056-well formats.
Jubin said all that is necessary to read the plate is a 96-well plate luminometer, in this case a Victor instrument made by PerkinElmer.
Jubin said his company uses steady glow luminescence, but if investigators want to develop another assay they could try bright glow or even flash luminescence He spoke with CBA News during a roundtable discussion on “ready-to-go” CBAs at the World Pharmaceutical Congress, held here this week.
“The goal was to develop a one-day assay designed to use the minimal amount of operator steps, and have a minimal cost for a maximum signal output.”
Neutekbio, based in Galway, Ireland, has been serving the European market but wanted to get a foothold in the US market, Neutekbio CEO Robert Erickson told CBA News this week.
“Since our first product was an interferon product, PBL seemed like a natural fit to help us distribute the product in the US,” Erickson said.
The next kit to become available will probably be a human type-2 IFN kit, which could debut before the end of this year, he added.
Also, Neutekbio is currently developing a similar human TNF alpha kit and human Toll-like receptor kit, specifically for TLR3 and TLR9, said Jubin. He said that any biological molecule that provides a signal could certainly be developed into this platform.
Jubin said that these assay kits could also potentially be used to screen siRNAs and neutralizing antibodies. He said the human type-1 IFN kit is being evaluated as one of five different platforms in Europe because the European Union is going to start screening MS patients for neutralizing antibodies.
In addition, Neutekbio is currently co-developing a murine IFN assay with PBL, Erickson said, to which PBL will have worldwide exclusive rights.
That assay may become available within the next several months, but the timeline for launch is up to PBL, which will develop, assemble, and market the assay, because it would be their product, Erickson said. Neutekbio would just supply the iLite technology
Probably the next thing Neutek will develop would be the TNF and TLR bioassays, and “we would likely talk to PBL about distributing that in North America,” Erickson said.