aka Live Biotherapeutic Product
According to the FDA guidelines on early clinical trials with live Biotherapeutics an LBP is “a biological product” that:
- contains live microorganisms, such as bacteria
- is applicable to the prevention, treatment, or cure of a disease or condition of human beings;
- is not a vaccine.
LBP’s are not filterable viruses, oncolytic bacteria, or products intended as gene therapy agents and, as a general matter, are not administered by injection. An example of an LBP, for the purposes of 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.