Next Generation Platform for the Production of Biopharmaceuticals

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".

Deadline for manuscript submissions: closed (31 May 2022) | Viewed by 2294

Special Issue Editor


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Guest Editor
Department of Molecular Science and Technology, Ajou University, Suwon 16499, Korea
Interests: mammalian cell culture engineering; genome editing technologies; mammalian systems/synthetic biology

Special Issue Information

Dear Colleagues,

The demand for biopharmaceuticals, such as therapeutic proteins, is increasing, and healthcare systems are facing tremendous costs to address unmet medical needs. Therefore, to meet the growing demand for biopharmaceuticals, the development of highly efficient production platforms is warranted. Although state-of-the-art industrial manufacturing processes allow productivity of over g/L for numerous monoclonal antibodies, the expansion of the biopharmaceutical industry pipeline with a wide range of non-native proteins, such as bispecific antibodies and fusion proteins, poses questions regarding both the manufacturability and timelines to achieve a commercially viable solution. This Special Issue aims to explore the emerging trends in the platforms and manufacturing processes for the production of biopharmaceuticals. In this Special Issue, original research articles and reviews are welcome. Research areas may include but not be limited to recent advances in mammalian-based production of biopharmaceuticals and manufacturing platforms, alternative mammalian expression platforms, including cell-free and gene-based expression systems, issues in manufacturing therapeutics in a non-native format, etc.  

Dr. Jae Seong Lee
Guest Editor

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Keywords

  • biopharmaceutical production using mammalian cells
  • mammalian cell culture engineering
  • alternative mammalian expression/manufacturing platform
  • cell-free expression system for therapeutic protein production
  • gene-based (DNA, RNA) biopharmaceutical production
  • non-native difficult-to-express therapeutic protein

Published Papers (1 paper)

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Research

14 pages, 2047 KiB  
Article
Enhanced Production of ECM Proteins for Pharmaceutical Applications Using Mammalian Cells and Sodium Heparin Supplementation
by Javier Garcia-Pardo, Sergi Montané, Francesc Xavier Avilés, Sebastian Tanco and Julia Lorenzo
Pharmaceutics 2022, 14(10), 2138; https://doi.org/10.3390/pharmaceutics14102138 - 8 Oct 2022
Viewed by 1633
Abstract
The yields of soluble ECM proteins recombinantly produced with mammalian cells can be significantly enhanced by exploiting the stabilizing properties of heparin. Here, we propose a simple and straightforward scalable protocol for the mammalian cell production of ECM proteins with affinity for heparin, [...] Read more.
The yields of soluble ECM proteins recombinantly produced with mammalian cells can be significantly enhanced by exploiting the stabilizing properties of heparin. Here, we propose a simple and straightforward scalable protocol for the mammalian cell production of ECM proteins with affinity for heparin, using heparin as a supplement. As proof of concept, we have demonstrated the high-level expression of four biomedically relevant human enzymes such as carboxypeptidase Z (CPZ), carboxypeptidase A6 (CPA6), beta-galactoside alpha-2,6-sialyltransferase 2 (ST6GAL1) and thrombin-activable fibrinolysis inhibitor (TAFI). We found a strong linear correlation between the isoelectric point (pI) of a protein and the improvement in protein expression levels upon heparin addition, providing a reference for selecting novel protein targets that would benefit from heparin supplementation. Finally, we demonstrated the compatibility of this approach with a three-step purification strategy that includes an initial heparin affinity purification step. Using CPZ as a representative example, we performed a preparative purification of this enzyme. The purified protein is enzymatically active and can be used for pharmaceutical applications as well as for high-throughput functional and structural studies. Full article
(This article belongs to the Special Issue Next Generation Platform for the Production of Biopharmaceuticals)
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