Challenges and Opportunities in the Oral Delivery of Recombinant Biologics

Recombinant biological molecules are at the cutting-edge of biomedical research thanks to the significant progress made in biotechnology and a better understanding of subcellular processes implicated in several diseases. Given their ability to induce a potent response, these molecules are becoming the drugs of choice for multiple pathologies. However, unlike conventional drugs which are mostly ingested, the majority of biologics are currently administered parenterally. Therefore, to improve their limited bioavailability when delivered orally, the scientific community has devoted tremendous efforts to develop accurate cell- and tissue-based models that allow for the determination of their capacity to cross the intestinal mucosa. Furthermore, several promising approaches have been imagined to enhance the intestinal permeability and stability of recombinant biological molecules. This review summarizes the main physiological barriers to the oral delivery of biologics. Several preclinical in vitro and ex vivo models currently used to assess permeability are also presented. Finally, the multiple strategies explored to address the challenges of administering biotherapeutics orally are described.

Automated summary

Recombinant biological molecules, due to progress in biotechnology and understanding of subcellular processes, have become cutting-edge in biomedical research. They are increasingly used as drugs for various diseases. However, their limited bioavailability when orally delivered has led to the development of accurate models to determine their capacity to cross the intestinal mucosa. Additionally, strategies to enhance their intestinal permeability and stability have been explored.