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Bulletin, Institute

Swallowing A Biologic Drug?

Original article posted on BioTech Primer

SURVIVING THE STOMACH IS KEY

Over the past two decades, biologic drugs — drugs composed of proteins produced by living cells — have become the safest, most effective top sellers within the pharmaceutical industry.

Approved to treat a variety of diseases including rheumatoid arthritis, diabetes, multiple sclerosis, Crohn’s disease, and a whole range of cancers, these drugs include monoclonal antibody therapeutics, hormones, and immune system signaling molecules. Their safety and efficacy depend largely on the complex, three-dimensional structure of the protein product itself — which is incredibly delicate and time-consuming to develop on a large scale. The majority of these are administered via injection directly into the bloodstream for maximum potency.

So, why can’t we just swallow a biologic pill? The simple answer: biologics would not survive the acidic pH and digestive enzymes of the gut. Even if survival were possible, the next issue to contend with is absorption; if the protein is not broken down properly, it will not be absorbed into the bloodstream. Companies seeking to develop oral delivery of biologics must overcome both hurdles.

Injectable delivery is cumbersome at best.  It has a significant impact on a patient’s quality of life, which in turn affects compliance to drug therapy regimes. In many cases, patients must make regular trips to an infusion center to receive required treatments. Thus oral administration is the holy grail in terms of delivering biologics. In this WEEKLY, we’ll take a look at the different paths being pursued to make this ambition a reality.

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