Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation

The advent of biopharmaceuticals in modern medicine brought enormous benefits to the treatment of numerous human diseases and improved the well-being of many people worldwide. First introduced in the market in the early 1980s, the number of approved biopharmaceutical products has been steadily incre...

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Main Authors: Leonor S. Castro, Guilherme S. Lobo, Patrícia Pereira, Mara G. Freire, Márcia C. Neves, Augusto Q. Pedro
Format: Article
Language:English
Published: MDPI AG 2021-04-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/9/4/328
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author Leonor S. Castro
Guilherme S. Lobo
Patrícia Pereira
Mara G. Freire
Márcia C. Neves
Augusto Q. Pedro
author_facet Leonor S. Castro
Guilherme S. Lobo
Patrícia Pereira
Mara G. Freire
Márcia C. Neves
Augusto Q. Pedro
author_sort Leonor S. Castro
collection DOAJ
description The advent of biopharmaceuticals in modern medicine brought enormous benefits to the treatment of numerous human diseases and improved the well-being of many people worldwide. First introduced in the market in the early 1980s, the number of approved biopharmaceutical products has been steadily increasing, with therapeutic proteins, antibodies, and their derivatives accounting for most of the generated revenues. The success of pharmaceutical biotechnology is closely linked with remarkable developments in DNA recombinant technology, which has enabled the production of proteins with high specificity. Among promising biopharmaceuticals are interferons, first described by Isaacs and Lindenmann in 1957 and approved for clinical use in humans nearly thirty years later. Interferons are secreted autocrine and paracrine proteins, which by regulating several biochemical pathways have a spectrum of clinical effectiveness against viral infections, malignant diseases, and multiple sclerosis. Given their relevance and sustained market share, this review provides an overview on the evolution of interferon manufacture, comprising their production, purification, and formulation stages. Remarkable developments achieved in the last decades are herein discussed in three main sections: (i) an upstream stage, including genetically engineered genes, vectors, and hosts, and optimization of culture conditions (culture media, induction temperature, type and concentration of inducer, induction regimens, and scale); (ii) a downstream stage, focusing on single- and multiple-step chromatography, and emerging alternatives (e.g., aqueous two-phase systems); and (iii) formulation and delivery, providing an overview of improved bioactivities and extended half-lives and targeted delivery to the site of action. This review ends with an outlook and foreseeable prospects for underdeveloped aspects of biopharma research involving human interferons.
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spelling doaj.art-f927502987774aa7badb7b1a5768ccc42023-11-21T13:44:50ZengMDPI AGVaccines2076-393X2021-04-019432810.3390/vaccines9040328Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and FormulationLeonor S. Castro0Guilherme S. Lobo1Patrícia Pereira2Mara G. Freire3Márcia C. Neves4Augusto Q. Pedro5CICECO–Aveiro Institute of Materials, Chemistry Department, University of Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro, PortugalCICECO–Aveiro Institute of Materials, Chemistry Department, University of Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro, PortugalCentre for Mechanical Engineering, Materials and Processes, Department of Chemical Engineering, University of Coimbra, Rua Sílvio Lima-Polo II, 3030-790 Coimbra, PortugalCICECO–Aveiro Institute of Materials, Chemistry Department, University of Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro, PortugalCICECO–Aveiro Institute of Materials, Chemistry Department, University of Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro, PortugalCICECO–Aveiro Institute of Materials, Chemistry Department, University of Aveiro, Campus Universitário de Santiago, 3810-193 Aveiro, PortugalThe advent of biopharmaceuticals in modern medicine brought enormous benefits to the treatment of numerous human diseases and improved the well-being of many people worldwide. First introduced in the market in the early 1980s, the number of approved biopharmaceutical products has been steadily increasing, with therapeutic proteins, antibodies, and their derivatives accounting for most of the generated revenues. The success of pharmaceutical biotechnology is closely linked with remarkable developments in DNA recombinant technology, which has enabled the production of proteins with high specificity. Among promising biopharmaceuticals are interferons, first described by Isaacs and Lindenmann in 1957 and approved for clinical use in humans nearly thirty years later. Interferons are secreted autocrine and paracrine proteins, which by regulating several biochemical pathways have a spectrum of clinical effectiveness against viral infections, malignant diseases, and multiple sclerosis. Given their relevance and sustained market share, this review provides an overview on the evolution of interferon manufacture, comprising their production, purification, and formulation stages. Remarkable developments achieved in the last decades are herein discussed in three main sections: (i) an upstream stage, including genetically engineered genes, vectors, and hosts, and optimization of culture conditions (culture media, induction temperature, type and concentration of inducer, induction regimens, and scale); (ii) a downstream stage, focusing on single- and multiple-step chromatography, and emerging alternatives (e.g., aqueous two-phase systems); and (iii) formulation and delivery, providing an overview of improved bioactivities and extended half-lives and targeted delivery to the site of action. This review ends with an outlook and foreseeable prospects for underdeveloped aspects of biopharma research involving human interferons.https://www.mdpi.com/2076-393X/9/4/328Interferonbiopharmaceuticalrecombinant DNAproductionpurificationbioprocess development
spellingShingle Leonor S. Castro
Guilherme S. Lobo
Patrícia Pereira
Mara G. Freire
Márcia C. Neves
Augusto Q. Pedro
Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
Vaccines
Interferon
biopharmaceutical
recombinant DNA
production
purification
bioprocess development
title Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
title_full Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
title_fullStr Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
title_full_unstemmed Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
title_short Interferon-Based Biopharmaceuticals: Overview on the Production, Purification, and Formulation
title_sort interferon based biopharmaceuticals overview on the production purification and formulation
topic Interferon
biopharmaceutical
recombinant DNA
production
purification
bioprocess development
url https://www.mdpi.com/2076-393X/9/4/328
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