also know as Live Biotherapeutic Product

According to the FDA guidelines on early clinical trials with Live Biotherapeutics, an LBP is “a biological product” that:  

is applicable to the prevention, treatment, or cure of a disease or condition of human individual
contains live microorganisms such as bacteria
is not a vaccine

LBPs are not filterable viruses, oncolytic bacteria, or products intended as gene therapy agents and, for general purposes, are not administered by injection.  An example of an LBP as referred to in this document, would be one or more strains of bacteria administered orally to treat patients with ulcerative colitis, or administered vaginally to prevent bacterial vaginosis.

A recombinant LBP is

“A Live Biotherapeutic Product composed of microorganisms that have been genetically modified through the purposeful addition, deletion, or modification of genetic material. A recombinant LBP which is subject to this guidance is likely to raise additional considerations and thus would require additional information to be submitted in an IND.

There are several different types of LBP :

  • Single strain
  • Multi strain – at least two different strains made independently then brought together in a capsule or sachet
  • Co-Culture – several strains grown together in the same bioreactor then lyophilised into a homogenous drug substance