Downstream Processing for Biopharmaceuticals Recovery

Mehta, Anu

doi:10.1007/978-3-030-01881-8_6

Cited by 11 publications

(9 citation statements)

References 106 publications

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“…The downstream process aims to remove impurities while maintaining the chemical structure and biological activity of the target molecule and includes the following steps: (i) extraction/isolation, comprising the initial recovery of the product; (ii) purification–capture and intermediate purification by the removal of contaminants from the recovered product, and; (iii) polishing, removing contaminants and unwanted forms of the biomolecule of interest formed during the previous steps of the downstream processing [ 40 , 85 ].…”

Section: Therapeutic Cloned Interferonsmentioning

confidence: 99%

“…Over the years, alternatives to the widely applied and effective column liquid chromatographic processes have been described, mostly aiming to overcome their high cost and limited capacity [ 85 ]. Consequently, new techniques have been suggested, such as aqueous two-phase systems (ATPS) [ 5 , 105 , 106 ], cationic surfactant-based reverse micellar extraction [ 107 ], and immunomagnetic microspheres [ 108 ], schematized in Figure 8 .…”

Section: Therapeutic Cloned Interferonsmentioning

confidence: 99%

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

et al. 2021

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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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Section: Therapeutic Cloned Interferonsmentioning

confidence: 99%

Section: Therapeutic Cloned Interferonsmentioning

confidence: 99%

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

et al. 2021

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“…It should be strongly noted that compulsory licensing has no potential for increasing access to the biologics mostly because of the absence of an obligation on the patent holder to make the compulsory know-how available to the licensee (Krauspenhaar, 2015). For the industrial exploitation of inventions, particularly complex ones such as biopharmaceuticals (Scott Morton et al, 2018;Mehta, 2019;Kornyo, 2017), the patent description is not enough to start manufacturing. In case of a licence agreement, the licensee can count on cooperation with the patent holder.…”

Section: Disadvantages Of Trips Regulation Concerning Compulsory Licementioning

confidence: 99%

“…Biologics have been on the pharmaceutical market for decades. The term "biopharmaceutical" was fi rst used in the 1980s to describe therapeutic proteins obtained by biotechnological processes (Mehta 2019). Because of the patent expiry (Yamauchi, 2018) observed recently on numerous biological medicines (reference products), a competitive version called biosimilars (not generics) (Geigert, 2019) has started to share the market (Stiff et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

Więckowski¹

2019

EEJTR

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A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, fi rst of all towards the regranting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder).

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“…Centrifugation is the most common approach in this regard. In the pilot and industrial scales, this technique requires expensive equipment with high energy consumption and scheduled repair and maintenance services [9,10]. Hence, there is a vast attempt to develop cell immobilization techniques as an efficient alternative for centrifugation.…”

Section: Introductionmentioning

confidence: 99%

Magnetic Immobilization of Pichia pastoris Cells for the Production of Recombinant Human Serum Albumin

et al. 2020

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Magnetic immobilization as a novel technique was used to immobilize recombinant Pichia pastoris (GS115 Albumin) cells to produce human serum albumin (HSA). In this regard, magnetic nanoparticles (MNPs) coated with amino propyl triethoxy silane (APTES) were synthesized. P. pastoris cells were decorated with MNPs via nonspecific interactions. Decorated cells were magneto-responsible and easily harvested by applying an external magnetic field. The efficiency of magnetic immobilization (Ei) for cell removal was in direct relation with the MNP concentration and time of exposure to the magnetic field. By increasing the nanoparticles concentration, cells were harvested in a shorter period. Complete cell removal (Ei ≈ 100) was achieved in ≥0.5 mg/mL of MNPs in just 30 s. HSA is produced in an extremely high cell density (OD ~20) and it is the first time that magnetic immobilization was successfully employed for harvesting such a thick cell suspension. After 5 days of induction the cells, which were immobilized with 0.25 to 1 mg/mL of nanoparticles, showed an increased potency for recombinant HSA production. The largest increase in HSA production (38.1%) was achieved in the cells that were immobilized with 0.5 mg/mL of nanoparticles. These results can be considered as a novel approach for further developments in the P. pastoris-based system.

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Downstream Processing for Biopharmaceuticals Recovery

Cited by 11 publications

References 106 publications

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

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

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

Magnetic Immobilization of Pichia pastoris Cells for the Production of Recombinant Human Serum Albumin

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