Dataset Information

Technoeconomic Modeling of Plant-Based Griffithsin Manufacturing.

ABSTRACT: Griffithsin is a marine algal lectin that exhibits broad-spectrum antiviral activity by binding oligomannose glycans on viral envelope glycoproteins, including those found in HIV-1, HSV-2, SARS, HCV and other enveloped viruses. An efficient, scalable and cost-effective manufacturing process for Griffithsin is essential for the adoption of this drug in human antiviral prophylaxis and therapy, particularly in cost-sensitive indications such as topical microbicides for HIV-1 prevention. The production of certain classes of recombinant biologics in plants can offer scalability, cost and environmental impact advantages over traditional biomanufacturing platforms. Previously, we showed the technical viability of producing recombinant Griffithsin in plants. In this study, we conducted a technoeconomic analysis (TEA) of plant-produced Griffithsin manufactured at commercial launch volumes for use in HIV microbicides. Data derived from multiple non-sequential manufacturing batches conducted at pilot scale and existing facility designs were used to build a technoeconomic model using SuperPro Designer® modeling software. With an assumed commercial launch volume of 20 kg Griffithsin/year for 6.7 million doses of Griffithsin microbicide at 3 mg/dose, a transient vector expression yield of 0.52 g Griffithsin/kg leaf biomass, recovery efficiency of 70%, and purity of >99%, we calculated a manufacturing cost for the drug substance of $0.32/dose and estimated a bulk product cost of $0.38/dose assuming a 20% net fee for a contract manufacturing organization (CMO). This is the first report modeling the manufacturing economics of Griffithsin. The process analyzed is readily scalable and subject to efficiency improvements and could provide the needed market volumes of the lectin within an acceptable range of costs, even for cost-constrained products such as microbicides. The manufacturing process was also assessed for environmental, health and safety impact and found to have a highly favorable environmental output index with negligible risks to health and safety. The results of this study help validate the plant-based manufacturing platform and should assist in selecting preferred indications for Griffithsin as a novel drug.

SUBMITTER: Alam A

PROVIDER: S-EPMC6066545 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Technoeconomic Modeling of Plant-Based Griffithsin Manufacturing.

Alam Aatif A Jiang Linda L Kittleson Gregory A GA Steadman Kenneth D KD Nandi Somen S Fuqua Joshua L JL Palmer Kenneth E KE Tusé Daniel D McDonald Karen A KA

Frontiers in bioengineering and biotechnology 20180724

Griffithsin is a marine algal lectin that exhibits broad-spectrum antiviral activity by binding oligomannose glycans on viral envelope glycoproteins, including those found in HIV-1, HSV-2, SARS, HCV and other enveloped viruses. An efficient, scalable and cost-effective manufacturing process for Griffithsin is essential for the adoption of this drug in human antiviral prophylaxis and therapy, particularly in cost-sensitive indications such as topical microbicides for HIV-1 prevention. The product ...[more]

PMID: 30087892

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Project description:The time when plant biostimulants were considered as "snake oil" is erstwhile and the skepticism regarding their agricultural benefits has significantly faded, as solid scientific evidences of their positive effects are continuously provided. Currently plant biostimulants are considered as a full-fledged class of agri-inputs and highly attractive business opportunity for major actors of the agroindustry. As the dominant category of the biostimulant segment, seaweed extracts were key in this growing renown. They are widely known as substances with the function of mitigating abiotic stress and enhancing plant productivity. Seaweed extracts are derived from the extraction of several macroalgae species, which depending on the extraction methodology lead to the production of complex mixtures of biologically active compounds. Consequently, plant responses are often inconsistent, and precisely deciphering the involved mechanism of action remains highly intricate. Recently, scientists all over the world have been interested to exploring hidden mechanism of action of these resources through the employment of multidisciplinary and high-throughput approaches, combining plant physiology, molecular biology, agronomy, and multi-omics techniques. The aim of this review is to provide fresh insights into the concept of seaweed extract (SE), through addressing the subject in newfangled standpoints based on current scientific knowledge, and taking into consideration both academic and industrial claims in concomitance with market's requirements. The crucial extraction process as well as the effect of such products on nutrient uptake and their role in abiotic and biotic stress tolerance are scrutinized with emphasizing the involved mechanisms at the metabolic and genetic level. Additionally, some often overlooked and indirect effects of seaweed extracts, such as their influence on plant microbiome are discussed. Finally, the plausible impact of the recently approved plant biostimulant regulation on seaweed extract industry is addressed.

Dataset Information

Technoeconomic Modeling of Plant-Based Griffithsin Manufacturing.

Publications

Technoeconomic Modeling of Plant-Based Griffithsin Manufacturing.

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