As cellular therapy emerges today as a new therapeutic approach, it faces similar challenges to those presented to biologics in the last decades, having to deal with new aspects of development, in particular product process development, generation of clinical evidence for regulatory decisions and models for market access.This entire value chain needs to support a business model and a benefit risk ratio that meets the expectations of all key stakeholders from investors and regulators, to prescribers,payers and, above all, patients.Autoimmune diseases, like Crohns Disease, represent a medical need that is only partially addressed with small molecule and biologics approach.Core to these pathologies is the de-regulation of the immune system including the regulatory T cell compartment.ASTrlA is a technology platform for the discovery and production of economically viable, autologous antigen-specific T regulatory cell therapies.Ovasave is the lead ASTrlA product, first to reach clinical stage development, targeting the treatment of Crohns Disease.Ovasave has shown good tolerability and clinical benefit in an initial open label study, CATS1, with Crohns disease patients refractory to existing treatments, including biologics.Currently a second multi-dose controlled study, CATS29, is starting.Essential to the anticipated success of Ovasave are the process development activities that ensure a robust and transferable manufacturing process as well as the competitive positioning of Ovasave to the existing third line biologic treatments.Aspects of product development and positioning together with the clinical evidence so far generated will be discussed to support Ovasave as a potential new significant opportunity for the management of patients with Crohns disease in the context of emerging cellular therapy approaches.