10 Features of the ATMPs development

There are several distinctive features that must be considered in the ATMP development:

  1. ATMPs are mainly for the unmet medical needs = severe, rare, or chronic diseases with no adequate conventional treatments.
  2. Risk-based approach = Dominant strategy of the ATMPs development.
  3. ATMP = strong scientific data + consistent/robust/aseptic manufacturing process.
  4. Early start with the potency assays development (mode of action/the intended effect).
  5. Quality = starting materials, raw materials, supply chain, etc.
  6. 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.

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