BioPharm International

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In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Career FDA Leaders Say Science Is Agency’s Guide

Welcome to BioPharm International&apos;s Guide to Formulation, Fill, and Finish, focused on pharmaceuticals — mainly proteins — produced by biologic means.

Introduction and Acknowledgements

absorption The process of a drug's movement from the administration site into systemic circulation.

Glossary

Biopharmaceutical formulation is primarily about stability and the product's mode of use. The route of administration (drug delivery, see next chapter) and the manufacturing process must be considered, along with the molecule's intrinsic stability factors. Because proteins and peptides are such large molecules and exist to interact with their environment, they are somewhat fragile. They must be protected from denaturation and degradation until they can be delivered to their site of action in a patient's body.

Author | BioPharm International