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Industrial Challenges of Recombinant Proteins

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Current Applications of Pharmaceutical Biotechnology

Part of the book series: Advances in Biochemical Engineering/Biotechnology ((ABE,volume 171))

Abstract

The use of recombinant DNA methods to produce large quantities of protein for therapeutic uses has revolutionized medicine. Industrial challenges for manufacture of biotherapeutic proteins are related to the characteristics of these proteins and the increasing quantities required to address needs of patients, worldwide. A brief overview of therapies in which proteins are employed helps to frame some of the challenges facing their industrial production. The number of molecules and their applications have significantly expanded over the last 15–20 years, together with the quantities used to address specific indications. Challenges addressed include achieving cell density, protein expression, separations of cells and protein, protein purification, and segmentation of protein production into smaller quantities with the evolution of personalized medicine and products designed for increasingly small patient populations. This chapter highlights some of the current challenges.

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Acknowledgments

The authors wish to acknowledge support from the College of Engineering from “Engineering Faculty Conversation on Future Manufacturing” and Hatch Act Support 10677 and 10646, Purdue University.

Author information

Authors and Affiliations

  1. RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA

    Scott R. Rudge

  2. Purdue University Laboratory of Renewable Resource Engineering, West Lafayette, IN, USA

    Michael R. Ladisch

Authors
  1. Scott R. Rudge
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  2. Michael R. Ladisch
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Corresponding authors

Correspondence to Scott R. Rudge or Michael R. Ladisch .

Editor information

Editors and Affiliations

  1. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    Ana Catarina Silva

  2. FP-ENAS (UFP Energy, Environment and Health Research Unit), CEBIMED (Biomedical Research Centre), Faculty of Health Sciences, Fernando Pessoa University, Porto, Portugal

    Ana Catarina Silva

  3. Center for Neurosciences and Cell Biology (CNC) and Faculty of Pharmacy (FFUC), University of Coimbra, Coimbra, Portugal

    João Nuno Moreira

  4. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    José Manuel Sousa Lobo

  5. UCIBIO, REQUIMTE, MEDTECH, Laboratory of Pharmaceutical Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal

    Hugo Almeida

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Rudge, S.R., Ladisch, M.R. (2019). Industrial Challenges of Recombinant Proteins. In: Silva, A.C., Moreira, J.N., Lobo, J.M.S., Almeida, H. (eds) Current Applications of Pharmaceutical Biotechnology. Advances in Biochemical Engineering/Biotechnology, vol 171. Springer, Cham. https://doi.org/10.1007/10_2019_120

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