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In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.
Therefore, a variety of excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Additionally, biopharmaceutical excipients act as bulking agents, antioxidants or preservatives.
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Drugs with a high potency are toxic even in small doses, and present a threat to human health, or run the risk of coming into contact with other drugs while being manufactured and compromising the quality. Of those, only 935 (34%) small molecule API facilities offered some type of containment capabilities.
Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.
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