Protein Therapeutic: Production, Application, and Future Scenario

Chaudhary, Renu; Balhara, Meenakshi; Chhillar, Anil Kumar

doi:10.1007/978-981-10-5511-9_4

Cited by 2 publications

(2 citation statements)

References 56 publications

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“…Therapeutic proteins are generally produced using living cells or microorganisms ( Lagassé et al, 2017 ). Moreover, proteins need to maintain their three-dimensional structure to be biologically active, which involves not only the correct sequence of amino acids but also proper folding and specific post-translational modifications ( Chaudhary et al, 2017 ). Since therapeutic proteins are synthesized using cell-based production systems, complex purification strategies are generally involved.…”

Section: Introductionmentioning

confidence: 99%

Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies

Sánchez‐Trasviña

Flores-Gatica

Enriquez-Ochoa

et al. 2021

Front. Bioeng. Biotechnol.

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Proteins, which have inherent biorecognition properties, have long been used as therapeutic agents for the treatment of a wide variety of clinical indications. Protein modification through covalent attachment to different moieties improves the therapeutic’s pharmacokinetic properties, affinity, stability, confers protection against proteolytic degradation, and increases circulation half-life. Nowadays, several modified therapeutic proteins, including PEGylated, Fc-fused, lipidated, albumin-fused, and glycosylated proteins have obtained regulatory approval for commercialization. During its manufacturing, the purification steps of the therapeutic agent are decisive to ensure the quality, effectiveness, potency, and safety of the final product. Due to the robustness, selectivity, and high resolution of chromatographic methods, these are recognized as the gold standard in the downstream processing of therapeutic proteins. Moreover, depending on the modification strategy, the protein will suffer different physicochemical changes, which must be considered to define a purification approach. This review aims to deeply analyze the purification methods employed for modified therapeutic proteins that are currently available on the market, to understand why the selected strategies were successful. Emphasis is placed on chromatographic methods since they govern the purification processes within the pharmaceutical industry. Furthermore, to discuss how the modification type strongly influences the purification strategy, the purification processes of three different modified versions of coagulation factor IX are contrasted.

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Section: Introductionmentioning

confidence: 99%

Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies

Sánchez‐Trasviña

Flores-Gatica

Enriquez-Ochoa

et al. 2021

Front. Bioeng. Biotechnol.

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show abstract

“…In addition, TPPs have the advantage of a shorter approval time by the Food and Drug Administration (FDA) compared to small‐molecule drugs (Leader et al, 2008). Up until 2015, around 225 therapeutic proteins were approved by the FDA, ranging from low molecular weight interferons, natural enzymes, and hormones to high molecular weight antibodies; there are currently several hundred therapeutic proteins in clinical trials (Chaudhary et al, 2017). The inherent advantages of TPPs and their versatility have guaranteed their development; about 40% of the 6000 ongoing clinical pharmaceutical products are biopharmaceuticals and 123 protein‐based products have been newly approved in the United States and European Union between 2014 and 2018 (Table 1).…”

Section: Introductionmentioning

confidence: 99%

Hot melt extrusion: An emerging manufacturing method for slow and sustained protein delivery

Zheng

Pokorski

2021

WIREs Nanomed Nanobiotechnol

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With the rapid development of the biopharmaceutical industry, an increasing number of new therapeutic protein products (TPPs) have been approved by the FDA and many others are under pre‐clinical and clinical evaluation. A major limitation of biopharmaceuticals is their limited half‐life when administered systemically. A one‐time, implantable, sustained protein delivery device would be advantageous in order to improve the quality of life of patients. Hot melt extrusion (HME) is a mature technology that has been extensively used for a broad spectrum of applications in the polymer and pharmaceutical industry and has achieved success as evidenced by a variety of FDA‐approved commercial products. These commercial products are mostly for sustained delivery of small molecule therapeutics, leaving a significant gap for HME formulation of therapeutic proteins. With the increasing need of sustained TPP delivery, HME shows promise as a downstream processing method due to its high efficiency and economic value. Several challenges remain for the application of HME in protein delivery. Progress of HME for protein delivery, challenges encountered, and potential solutions will be detailed in this review article. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Biology‐Inspired Nanomaterials > Protein and Virus‐Based Structures

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Protein Therapeutic: Production, Application, and Future Scenario

Cited by 2 publications

References 56 publications

Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies

Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies

Hot melt extrusion: An emerging manufacturing method for slow and sustained protein delivery

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