The fate of inhaled particles and ability to predict interactions that determine lung health largely remain unknown. One third of inhaled medicines fail in preclinical in vivo studies due to the presence of abnormal alveolar macrophage morphology. ImmuONE has established a robust human in vitro 3D model of the alveolus, ImmuLUNGTM, which includes of alveolar epithelial cells type I and alveolar-like macrophages. Currently, we are evolving a version of ImmuLUNGTM comprising alveolar epithelial cells type I and type II with immune cells to allow reporting of a broader array of biological interactions and endpoints.
Following successful completion on the phase 1 challenge awarded to ImmuONE by the NC3Rs, we were announced as the winners for the phase 2 challenge in January 2022. Sponsored by Unilever and AstraZeneca the project aims to establish and develop in vitro OECD test guidelines. These assays will be free from animal-derived products and demonstrate their equivalence and improved human relevance to current strategies. Once optimised, these technologies will be progress to a commercially ready, human relevant, animal-free bioassays with the view to gaining regulatory acceptance.
IPF is a progressive lung disease which causes scarring and an irreversible decline in lung function. Despite huge investments each year to develop new treatments for IPF, few new medicines have made it to market due to inadequate support by pre-clinical assessments. ImmuONE is working on a solution to this by developing and validating a pre-clinical 3D human in vitro cell culture platform which accurately mimics pathological inflammatory processes in the human alveolus during IPF. Preliminary data preformed in the area has shown human alveolar applicability along with cell longevity. We are now in the early stages of platform development for the pathological cell platform and actively looking for a partner to help us in the efficacy testing of this innovation in the IPF arena.
Currently, there is an increasing interest in moving away from animal research by incorporating the 3R approach (Animal Replacement, Reduction, Refinement). Furthermore, human cell culture assays have demonstrated the potential to represent human-relevant responses rapidly and more accurately.
ImmuONE is developing animal-free products for ImmuLUNG™ and ImmuPHAGE™ by substituting foetal bovine serum (FBS) for chemically defined serum (CDS) to support a more fitting approach that also enables the manufacturing a standardised in vitro mode with reproducible results. Our preliminary studies show that our immune cells can be safely cultured in animal product free medium whilst maintaining equivalent health, morphology and functionality.
Cell cultures, specifically immune cell cultures are highly sensitive to change in environments for example, shipping conditions. These changes adversely affect immune cell characteristics beyond viability and are usually not accounted for during the shipping- validation process. Several of ImmuONE’s customers wish to conduct in-house testing and inquire about obtaining in vitro models directly from us. In response, we’ve identified a routine shipping platform to transport our models directly to end users as an off-the-shelf product. While undergoing assessment for robustness, the systems are aimed to preserve ImmuONE products during transportation with a guarantee of their survival performance and quality assurance.