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Insights on the Formulation of Recombinant Proteins

  • Rita Ribeiro
  • Teresa Raquel Abreu
  • Ana Catarina Silva
  • João Gonçalves
  • João Nuno MoreiraEmail author
Chapter
Part of the Advances in Biochemical Engineering/Biotechnology book series (ABE, volume 171)

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.

Graphical Abstract

Keywords

Formulation Immunogenicity Recombinant proteins Stability 

Notes

Acknowledgments

Rita Ribeiro is a student of the Ph.D. Program in Pharmaceutical Sciences from the Faculty of Pharmacy, University of Coimbra, and a recipient of the fellowship SFRH/BD/121935/2016 from the Portuguese Foundation for Science and Technology. This work was funded by Portuguese National funds via FCT – Fundação para a Ciência e a Tecnologia, I.P. – under projects Cancel Stem (reference POCI-01-0145-FEDER-016390), CENTRO-01-0145-FEDER-000012 (HealthyAging2020), Euronanomed2 (FCT reference ENMed/0005/2015), and CNC.IBILI (FCT reference UID/NEU/04539/2019).

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Rita Ribeiro
    • 1
    • 2
  • Teresa Raquel Abreu
    • 1
    • 2
  • Ana Catarina Silva
    • 3
    • 4
  • João Gonçalves
    • 5
  • João Nuno Moreira
    • 1
    • 2
    Email author
  1. 1.CNC – Center for Neuroscience and Cell Biology, Faculty of Medicine (Pólo I)University of CoimbraCoimbraPortugal
  2. 2.FFUC – Faculty of PharmacyUniversity of CoimbraCoimbraPortugal
  3. 3.UCIBIO, UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of PharmacyUniversity of PortoPortoPortugal
  4. 4.FP-ENAS (UFP Energy, Environment and Health Research Unit), CEBIMED (Biomedical Research Centre), Faculty of Health SciencesUniversity Fernando PessoaPortoPortugal
  5. 5.iMed.ULisboa – Research Institute for Medicines, Faculty of PharmacyUniversity of LisbonLisbonPortugal

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