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Small molecule API: Shining a spotlight on new innovations in milling

Pharmaceutical Technology

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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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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A winning combination: The benefits of micronization and containment in a single installation

Pharmaceutical Technology

Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contract manufacturing facilities.