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http://www.pharma-planta.net
Prof. Julian Ma,
Prof. Rainer Fischer,Fraunhofer IME, Aachen
Dr. Julia Boyle,University of SurreyClinical Research Centre, Guildford
Prof. Maurice Moloney,Rothamsted Research, Harpenden
Pharma-Planta
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Recombinant Pharmaceuticals fromPlants for Human HealthA public consortium comprising
28 Academic Institutes and 3 Small/medium companies.
Funding period 2004 2009.12M Euros of EU public funding.
http://www.pharma-planta.net
The Pharma-Planta Project
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In 2009, 23M infants worldwidewere not reached by routine
immunization services
1.7M children under the age of 5 diedfrom vaccine-preventable diseases in2008
(WHO Global Immunisation Data; 2010)
The drive for the Pharma-Planta projectcomes from the need to produce modernmedicines economically and in sufficientquantities to meet global demand.
Global access to medicine
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An unprecedented opportunity to produce valuable medicinesaffordably and on a massive scale.
Molecular Farming
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Good manufacturing practice (GMP) is part of a quality systemcovering the manufacture and testing of pharmaceuticals.GMP regulations require (by law) that drug manufacturers ensuretheir products are safe, pure and effective.
Manufacturing processes must be clearly defined, controlled andconsistent.
GMP regulations are designed to minimize or eliminate
contamination and errors. This protects the consumer fromproducts that are dangerous or ineffective.
The challenge of making approvedpharmaceuticals from plants
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Mammalian cells current industrystandard.
Cell culture. A highly controlled and defined,sterile process
High-tech and expensive
Limited scalability
Plants
Cultivation of whole plants
A variable biological system
Non-sterile
Low-tech and inexpensive
Massive scalability
Manufacture of monoclonal antibodies
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To move beyond proof of concept anddevelop candidate products for clinicalevaluation in Phase I human trials
Monoclonal antibodies against two major diseases:HIV (passive immunization and microbicidal use)
Rabies (passive immunization)
Pharma-Planta Primary Objective
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Greenhouse
29 d
26 d
33 d
Scaled-up production
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41 d 44 d
Harvested tobacco
Scaled-up production
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DisruptionFiltration
Filtered tobaccoextract
Downstream processing
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Greenhouse Production of rAb 2G12 in Tobacco
Cultivation transgenic tobacco plantscultivated for 45 days in greenhouse
Harvesting leaves chopped andshredded in 250-kg batches
GMP downstream processing using acustom process, >5 g of pure antibody
Toxicology product non toxic in rabbits Clinical trial phase I trial in humans
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Double-blind, placebo controlled, first in woman Dose escalation: 7, 14 and 28 mg
Objectives:
Evaluate safety: clinical safety tests, local
reactions, adverse events
Evaluate P2G12 concentration in blood and
vaginal secretions
A Phase I study of P2G12 as a vaginal microbicide
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Phase I P2G12 safety trial
Study schedule
Dosing
7 mg, 28th June 2011.
3 subjects (2x P2G22, 1x placebo)
14 mg, 19th July 2011.
3 subjects (2x P2G12, 1x placebo)
28 mg, 30th August 2011.
5 subjects (4x P2G12, 1x placebo) Preliminary results 17th October 2011
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The Significance of Monoclonal Antibodies
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The Significance of Monoclonal Antibodies
Major products in biotechnology and clinical care
Injectable, topical and oral applications
Licensed products already available for:
Cancers (avastin, herceptin)
Infectious disease (Synagis)
Chronic diseases (infliximab, rituximab)
Many pipeline products
Typical costs 10-15,000 /patient/yr
S
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Pharma-Planta a publicly funded academicconsortium.
A unique plant biotechnologymanufacturing facility in Aachen, Germany.
The GMPmonoclonal antibody drug product from
plants has been approved in UK.
-derived Mab.
Opening the potential of plants to manufacture a range ofdrugs for the developed and developing world.
Our thanks to the European Union Framework 6 Programme forfunding this work.
Summary
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