Q. What is innovative about the science at Alcyomics?
A. We use primary human cells and real human skin to replicate a human immune response to your compound of interest. We bridge the gap between safety tests in animal models and human in vivo
Q. How can Alcyomics help in the drug development process?
A. Skimune® identifies safety concerns for humans during the pre-clinical drug discovery process. We can generate data to help you further understand the mechanism of action of your compound, efficacy and aspects of safety early in the drug development process enabling “stop” or “go” decisions reducing drug development risks and costs.
Q. What is the service turnaround time?
A. This mostly depends on the client’s needs and what questions they want answered. Our service is usually delivered in phase’s e.g.
- Service Delivery Phase 1 – Protocol development with the client for testing out reagent (antibody, inhibitor, cellular therapeutic, chemical etc.)
- Service Delivery Phase 2 – Skimune® Assays & Results
- Service Delivery Phase 3 – Report & consultation
A single assay takes approx 10 days and on average our service delivery from beginning to end takes from 2 to 8 weeks depending on the service required. This could include, dose response assessments, individual variation of responses, immunohistochemistry and cytokine analysis. After the initial service and consultation in Phase 1 the protocols can be modified or expanded as clients require. All services are provided after detailed discussion with our clients to ensure the service meets all their requirements.
Q. Is the Skimune® technology validated?
A. We have validated the Skimune® technology with the gold standard animal model, the EU European Committee for the Validation of Alternative Methods (ECVAM), mouse Local Lymph Node Assay (LLNA). Comparative data sets are as follows:
- Skimune®Chem cf Local Lymph Node Assay (LLNA-mouse model)
- Number of positive LLNA chemicals = 21 Skimune®Chem prediction of positive chemicals = 21
- Number of negative LLNA chemicals = 20 Skimune®Chem prediction of negative chemicals = 19
- 100% specificity and 95% sensitivity, concordance (98%)
- Validation of the methodology including, reproducibility, robustness, individual variation and assessment in differing skin culture conditions is part of our in house quality assurance.
A scientific publication on this subject can be found at PubMed
Q. How are the tests performed?
A. The Skimune® uses human skin explants in vitro which are treated with primary cells isolated from blood from the same individual and treated with the compound of interest. The compound can be added at different stages of the assay depending on the type of safety or efficacy information the client requires.