The Early Safety Screening Cytotoxicity assay is a high throughput testing model used for in vitro toxicity assessment that comprises five prevalidated human primary cell lines.
The second new assay - Immunosignal cytokine storm - is used to assess if a developmental biologic drug candidate is likely to induce a massive release of proinflammatory cytokines – or cytokine storm – using peripheral mononuclear blood cells.
In vitro assay plans
A spokeswoman for Concord, Ohio-based Ricerca told Outsourcing-pharma.com that development of the new assays was a logical expansion of the firm’s pharmacology business.
“Ricerca’s premier pharmacology service develops and provides assays that identify potential liabilities of a compound early in the drug discovery and development stage.
“With this goal in mind, we developed the primary cell toxicity assay as well as the Immunosignal cytokine storm assay. We will be adding several new assays in this in vitro functional toxicity space.”
Ricerca plans to make the new tests available to biotechnology and pharmaceutical companies as well as firms developing biologics, antibodies and vaccines for which the Immunosignal assay has be specifically developed.
The risk posed by cytokine storms came to prominence in 2006 when – during first in human studies - an immunotherapeutic called TGN1412, developed by German biotechnology company Tegenero, induced such reactions in six volunteers involved in the trial.
Since then - and in response to regulatory demands - academics and preclinical CROs have sought to develop in vitro tests that can assess if candidate monoclonal antibodies (MAbs), biologics or vaccines are likely to induce cytokine storms as early as possible in the development cycle.
This was certainly a motivation for Ricerca, which said that “Cytokine storm has recently been associated with monoclonal antibody therapy."
Usha Warrior, Ricerca technical director of in vitro pharmacology, said that: “Bringing these crucial screening assays to the earliest stages of drug discovery with this cost-effective model liberates our clients from having to invest capital and time.
“Ricerca has the capacity to screen hundreds of compounds a week with these new assays.”