There are several distinctive features that must be considered in the ATMP development:
- ATMPs are mainly for the unmet medical needs = severe, rare, or chronic diseases with no adequate conventional treatments.
- Risk-based approach = Dominant strategy of the ATMPs development.
- ATMP = strong scientific data + consistent/robust/aseptic manufacturing process.
- Early start with the potency assays development (mode of action/the intended effect).
- Quality = starting materials, raw materials, supply chain, etc.
- Preclinical safety assessment (immunogenicity, biocompatibility, viral or bacterial contamination, ectopic tissue formation, tumorigenicity, mutagenesis, tropism and tissue distribution, stability, biodistribution, shedding, etc.).
hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
