A regulated new class of medicines

Live biotherapeutics are a recognised and regulated new therapeutic class. In 2012, the FDA released its first guidelines on regulation of live biotherapeutics for clinical trials. Like other therapeutic classes, there are well defined guidelines on how live biotherapeutics should be characterised prior to the commencement of clinical trials. This includes definitions and examples of accepted assays for identity, purity, potency and stability.

The latest version of the FDA guidelines on live biotherapeutics was released in June 2016. A copy of this document can be found here.


An LBP, for the purposes of this guidance document, is a biological product that:

  1. contains live organisms, such as bacteria;
  2. is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and
  3. is not a vaccine.
FDA Guidance for Industry Early Clinical Trials with Live Biotherapeutic Products; June 2016.

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