Liaison(s): Aruna Perera, Aaron Scalia, Christopher Wahl
The TMP Project focused on drug delivery through an ingestible device and its applications to the gastrointestinal (GI) tract. Our team has explored the delivery of different monoclonal antibodies (mAbs) such as Adalimumab (Humira), Infliximab (Remicade) and Vedolizumab (Entyvio) for treating inflammatory bowel disease (IBD); specifically, Crohn’s disease and ulcerative colitis.
The team was tasked with delineating the active pharmaceutical ingredients and drug products of the mAbs, in addition to characterizing the environment of the distal jejunum, ileum and colon. An analysis of literature, patents, and market review was conducted to understand current competitive intelligence available. Accomplishing this task required in-depth analysis of scientific literature and speaking to various Key Opinion Leaders (MD’s and PhD’s) from nationally recognized conferences. In combination with data obtained from laboratory experiments testing the effects of mAbs on in vitro animal models with induced IBD, the team identified the implications of the GI environment on the tissue absorption, stability and potency of the mAbs. Lastly, the team recommended optimal delivery approaches for each mAb and associated validation and test plan.