An integral approach towards a practical application for a plant-made monoclonal antibody in vaccine purification

Pujol, Merardo; Ramírez, Nadia; Ayala, Marta; Gavilondo, Jorge V.; Valdés, Rodolfo; Rodríguez, M.; Brito, José A.; Padilla, Sigifredo; Gómez, Leonardo D.; Reyes, Biunaiky; Peral, R.; Perez, Marisol; Marcelo, José; Milá, Lorely; Sánchez, Rafael; Páez, Rolando; Cremata, José A.; Enríquez, G. A.; Mendoza, Otto; Ortega, Mercedes; Borroto, Carlos

doi:10.1016/j.vaccine.2004.11.023

Cited by 61 publications

(25 citation statements)

References 18 publications

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“…The main species being considered in the non-food category are tobacco and falseflax. Tobacco is a strong candidate for the commercial production of recombinant proteins since it already has a track record in PMP research (Stoger et al 2002) and has recently been used in Cuba for the commercial production of a recombinant antibody against hepatitis B (Ramirez et al 2003;Valdé s et al 2003;Pujol et al 2005). The major advantages of tobacco include efficient, wellestablished methods of gene transfer and expression, high biomass yields (due to multiple cropping ability), plentiful seed production and a Transgenic Res (2007) 16:147-161 149 well-established infrastructure for large-scale processing.…”

Section: (I) Non-cultivated Speciesmentioning

confidence: 99%

Pharma-Planta: road testing the developing regulatory guidelines for plant-made pharmaceuticals

et al. 2007

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Significant advances over the last few years have seen plant-made pharmaceuticals (PMPs) move from the exploratory research phase towards clinical trials, with the first commercial products for human use expected to reach the market by 2009. Europe has yet to witness the commercial application of PMP technology, although at least one product has begun phase II clinical trials with others following close behind. These emerging products are set to challenge the complex and overlapping regulations that currently govern GM plants and 'conventional' pharmaceutical production. The areas of responsibility are being mapped out between the different EU regulatory agencies, with specific guidelines currently being drawn up for the regulation of PMPs. This article discusses issues surrounding the development of robust risk-assessment and risk-management practices based on health and environmental impact, while working with EU regulatory authorities to ensure appropriate regulatory oversight.

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Section: (I) Non-cultivated Speciesmentioning

confidence: 99%

Pharma-Planta: road testing the developing regulatory guidelines for plant-made pharmaceuticals

et al. 2007

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“…The large-scale production of scFv in transgenic Nicotiana and its use for immunopurification of Hepatitis B surface antigen for a vaccine has been described. 60 Lab scale purification of Nictotiana-derived HSV glycoprotein D (gD)-a potential vaccine antigen-has been used with transiently expressed full length anti-gD mAb from Nicotiana (personal communication, Hugh Mason). Although economically desirable, the use of mAbs for industrial purification of target antigens is not currently routine.…”

mentioning

confidence: 99%

Emerging antibody products and Nicotiana manufacturing

2011

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“…A tobacco-derived antibody was also approved by Cuban authorities in 2006 as an affinity purification reagent for a hepatitis B vaccine produced in yeast (67). Although this antibody is not used as a pharmaceutical, it nevertheless had to meet GMP standards as part of the vaccine manufacturing process.…”

Section: Analytical Applications Of Antibodies Produced By Molecular mentioning

confidence: 99%

Plant Molecular Farming: Much More than Medicines

Tschofen

Knopp

Hood

et al. 2016

Annual Rev. Anal. Chem.

148

103

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Plants have emerged as commercially relevant production systems for pharmaceutical and nonpharmaceutical products. Currently, the commercially available nonpharmaceutical products outnumber the medical products of plant molecular farming, reflecting the shorter development times and lower regulatory burden of the former. Nonpharmaceutical products benefit more from the low costs and greater scalability of plant production systems without incurring the high costs associated with downstream processing and purification of pharmaceuticals. In this review, we explore the areas where plant-based manufacturing can make the greatest impact, focusing on commercialized products such as antibodies, enzymes, and growth factors that are used as research-grade or diagnostic reagents, cosmetic ingredients, and biosensors or biocatalysts. An outlook is provided on high-volume, lowmargin proteins such as industrial enzymes that can be applied as crude extracts or unprocessed plant tissues in the feed, biofuel, and papermaking industries.

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An integral approach towards a practical application for a plant-made monoclonal antibody in vaccine purification

Cited by 61 publications

References 18 publications

Pharma-Planta: road testing the developing regulatory guidelines for plant-made pharmaceuticals

Pharma-Planta: road testing the developing regulatory guidelines for plant-made pharmaceuticals

Emerging antibody products and Nicotiana manufacturing

Plant Molecular Farming: Much More than Medicines

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