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2020 | OriginalPaper | Buchkapitel

Insights on the Formulation of Recombinant Proteins

verfasst von : Rita Ribeiro, Teresa Raquel Abreu, Ana Catarina Silva, João Gonçalves, João Nuno Moreira

Erschienen in: Current Applications of Pharmaceutical Biotechnology

Verlag: Springer International Publishing

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Abstract

Recombinant proteins are large and complex molecules, whose therapeutic activity highly depends on their structure. Formulation of biopharmaceuticals aims at stabilizing protein conformation, promoting its efficacy, and preventing safety concerns, such as immunogenicity. Currently, the rational design of formulations is possible due to the availability of several techniques for molecule characterization and an array of both well-known and new excipients. Also, high-throughput technologies and Quality by Design approaches are trending and have been contributing to the advancement of the field. Still, there is a search for alternatives that ensure quality of the medicines through its life cycle, particularly for highly concentrated formulations, such as monoclonal antibodies. There is also a demand for strategies that improve protein delivery and more comfortable administration to the patients, especially with the arising of recombinant proteins in the treatment of chronic diseases, such as autoimmune conditions or heart diseases. In this chapter, current and future advancements regarding recombinant protein formulation and its impact in drug development and approval will be addressed.

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Metadaten
Titel
Insights on the Formulation of Recombinant Proteins
verfasst von
Rita Ribeiro
Teresa Raquel Abreu
Ana Catarina Silva
João Gonçalves
João Nuno Moreira
Copyright-Jahr
2020
Verlag
Springer International Publishing
DOI
https://doi.org/10.1007/10_2019_119

    Marktübersichten

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