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Therapeutic proteins are rarely available in oral dosage form because the hostile environment of the human gastrointestinal (GI) tract and their large size make this delivery method difficult
Oral delivery of therapeutic proteins is often thought to be impossible because of their size and the hostile environment in the human GI tract
Experience with intestinal bacteria and their products indicates that the intestinal barriers are not insurmountable.
Commensal Bacteria / Commensalism in the gut can be engineered to produce therapeutic proteins. In doing so, the experience of producing recombinant proteins by E. coli strains produced in the laboratory is used
Oral administration of Lactococcus lactis to produce human pro-insulin is in clinical trials for the treatment of type 1 diabetes (NCT03751007 - AG019 vs AG019 + Teplizumab & Type 1 Diabetes (T1D))
Lactobacillus and Bifidobacterium can produce Bacterial Biofilm / Microbial Biofilm (BF). Therefore, biofilm-forming bacteria can be engineered to produce and secrete therapeutic proteins into the biofilm matrix, providing protection from gastric acid degradation and enhancing absorption
Breaking through intestinal barriers is key to successful oral administration of Therapeutic Proteins
see also:
Nanoparticles
Live bacterial therapeutics (LBTs) / Next-Generation Live Biotherapeutics / Engineered Microbial Organisms