[MPWG] Conference on Plant-Made Pharmaceuticals
Sonya
msredsonya at earthlink.net
Fri Jan 28 00:08:55 CST 2005
The info, links, and sites below, obviously, would not be pro native
plant or
high on the list for conservation. It is simply for information purposes
only.
I receive the International Biopharm Journal because of the material
covering transgenic, molecular, and technological information.
One needs to know what is transpiring on the other side of the fence. :)
Anyhow.......I received the first link regarding the conference on plant
made pharmaceuticals
from biopharm in an email. The rest of the material I added. Hope I did
not bore anyone too much. Sonya
The Conference on Plant-Made Pharmaceuticals emphasizes downstream
processing:
plant-specific cellular targeting technologies, recovery by magnetic fields,
tags and plant-specific protein recovery systems.
Regulatory, public opinion and financial issues are also discussed.
(www.cpmp2005.org
<http://listmgr.advanstar.com/t/237132/9736983/456785/0/>).
The said to be useful links that were on the cpmp site.
Information on PMPs
www.plantpharma.org
A project of the International Academy of Life Sciences proposing
information about the related life sciences area of plant-made
pharmaceuticals.
www.isb.vt.edu
Information Systems for Biotechnology ISB, an independent information
source on contemporary agriculture, with a good coverage of
plant-factories, field trials, and technology development Agricultural
Experiment Station at Virginia Tech, USA.
www.pewagbiotech.org
Pew Initiative on Food and Biotechnology, an independent and objective
source of credible information on agricultural biotechnology for the
public, media and policymakers-promote public dialogue on regulatory
systems, food safety and environment, with a good coverage of
plant-factories.
www.bio.org/healthcare/pharmaceutical/pmp
Biotechnology Industry Organization's pages on Plant-made
Pharmaceuticals PMPs with best-practice documents, factsheets,
information on government regulation, and news USA.
www.carc-crac.ca/english/biobased%20molecular%20page.htm
Minutes of the "Bio-Based Molecular Production Systems Workshop" held in
April 2004 in Ottawa, Canada, toward a policy framework for the
responsible commercialization of plant- and animal- made pharmaceuticals.
www.meetingsmanagement.com/pbva_2005
ThePlant-based Vaccines & Antibodies 2005 Conference will be held
inPrague, Czech Republic, June 8-10, 2005, chaired by Dr. Julian Ma,
withseveral organizers from the Annecy meeting in March 2005, including
Dr.Charles Arntzen from ASU.
=========================
snip-----
Plant-Made Pharmaceuticals
Plant-Made Pharmaceuticals (PMPs) is a category of therapeutic agents
(pharmaceutical proteins) produced in live plants. Crops such as corn,
tobacco, rice and soy are genetically altered to yield proteins with
purity and activity equivalent to those produced by other manufacturing
systems, with advantages that include large volume production capacity,
reduced capital requirements, and freedom from potential viral and
animal protein contamination
http://www.bio.org/healthcare/pharmaceutical/pmp/
snip-----
Which government agencies oversee the production of plant-made
pharmaceuticals?
Plant-made pharmaceutical (PMP) production is regulated under stringent
requirements of the U.S. Department of Agriculture (USDA) and the Food
and Drug Administration (FDA). Several agencies within USDA and FDA
regulate and monitor PMPs, including USDA's Animal and Plant Health
Inspection Service (APHIS) under the Biotechnology Regulatory Services
(BRS), the FDA Center for Biologics Evaluation and Research (CBER), FDA
Center for Drug Evaluation and Research (CDER), FDA Center for Food
Safety and Applied Nutrition (CFSAN) and FDA Center for Veterinary
Medicine (CVM).
http://www.bio.org/healthcare/pharmaceutical/pmp/factsheet4.asp
================
This is the list from the federal government for the release permits for
plant biotechnology applications, I only included the first one from the
list to give
an example of how it the list is displayed, it is a long list. The
permit files are here, if the permit was approved
http://www.aphis.usda.gov/brs/ph_permits.html, for most
of the files, anyhow.
Current status of Release Permits
--------------------------------------------------------------------------------
1/27/05 2:09 am
Release Permits under 7 CFR Part 340
All applications
Sorted in reverse order by BP number.
Biotechnology Regulatory Services
USDA, APHIS, BRS
Riverdale, MD 20737
Telephone 301-734-7324
*******************************************************************************
1. 05-025-01r SemBioSys Genetics Reg article: Safflower / OO / Release
State: WA Reviewer: VM Receive: 1/25/05 Status: Pending
snip
http://www.aphis.usda.gov/brs/industrial_biotech.html
Press Release
Meghan Thomas (301) 734-3266
Jerry Redding (202) 720-6959
USDA TO REQUIRE PERMITS FOR ALL INDUSTRIAL BIOTECH PLANTS
WASHINGTON, Aug. 5, 2003--The U.S. Department of Agriculture's Animal
and Plant Health Inspection Service is amending its biotechnology
regulations as they pertain to plants designed to produce industrial
compounds. Entities wishing to move, field test or import these types of
engineered plants must apply for a permit.
Previously, APHIS allowed companies and institutions to field test, move
or import plants genetically engineered to produce industrial compounds
under its notification process, which is an expedited permitting
procedure. The notification process was originally added to the
biotechnology regulations in 1993 in order to expedite introductions for
genetically engineered plants considered low risk and developed using
genetic modifications with which APHIS was already familiar. Previous
notifications issued for genetically engineered industrial plants
involved plants in which nutritional components, such as oil content,
were being engineered.
=====================
Intellectual Property: Broad and Exclusive
Biolex has broad genetic engineering and technology patents resulting in
the Company’s exclusive control of the LEX System™, along with
freedom-to-operate. Through its acquisition of Epicyte Pharmaceutical,
Biolex has acquired the dominant intellectual property position covering
the production of antibodies in plants. Biolex’ exclusive control of the
above patent portfolios is complemented by selective licensing of
certain enabling technologies giving Biolex full freedom-to-operate to
manufacture therapeutic proteins in plants of the family Lemnaceae.
LEX System™
A fundamental patent for the genetic manipulation of the family
Lemnaceae issued on March 31, 2000 (U.S. patent number 6,040,498). This
patent, entitled “Genetically Engineered Duckweed,” was exclusively
licensed on a worldwide basis by Biolex from North Carolina State
University. The corresponding international application published on
February 18, 1999 (WO 99/07210). The issued patent consists of 65 claims
with 13 claims drawn to transformed duckweed and 27 claims drawn to
transforming duckweed. In summary, these claims include: methods of
transformation and selection; methods of transgenic plant regeneration;
methods of growth and recovery; use of multiple genes and vectors; and
transformed tissue and plants.
A corresponding Australian patent (#755,632) issued on April 17, 2003.
A second Biolex PCT patent application entitled “Expression of
Biologically Active Polypeptides in Duckweed” published on February 7,
2002 (WO 02/10414 A2). The patent application has 34 claims. In summary,
these claims include: methods and compositions for expression; methods
and compositions for recovery; methods for enhanced expression levels;
and methods for directed secretion.
A third series of PCT patent applications cover Biolex’ unique ability
to automate the LEX System™ commercial line creation technology
(transformation, selection and screening). The PCT application entitled
“Plate and Method for High Throughput Screening” published on December
5, 2002 (WO 02/097029); the application entitled “Use of Duckweed in
High Throughput Screening” also published on December 5, 2002 (WO
02/097433). A U.S. patent (number 6,680,200) entitled “LED Array for
Illuminating Cell Well Plates and Automated Rack System for Handling the
Same” issued on January 20, 2004.
Plantibodies™
Biolex announced the acquisition of Epicyte Pharmaceutical, Inc., on May
6, 2004. Through Epicyte, Biolex has acquired the dominant intellectual
property position covering the production of antibodies in plants.
In September 1997, The Scripps Research Institute granted to Epicyte an
exclusive, worldwide license to the entire patent estate which covers
the expression of human and other antibodies in plants and serves as a
basis for our Plantibodies™ technology. In July 2002, U.S. patent
6,417,429 issued, extending the Plantibodies™ patent protection to all
species of transgenic plants that produce an antibody and methods of
making the transgenic plants. In addition, the Plantibodies™ portfolio
includes issued patent claims to plant-made antibody compositions and
their methods of use.
Patents Patented Inventions
US 5,202,422 Composition Claims
US 5,639,947 Ig/Transgenic Plants
US 5,959,177 Secretory Antibodies
US 6,417,429 Ig/Transgenic Plants
EP 497904 Ig/Transgenic Plants
JP 3238700 Ig/Transgenic Plants
Pending Plantibodies™ patents include additional claims to transgenic
plants expressing other multimeric proteins, immunization strategies,
pharmaceutical compositions and plant-based manufacturing methods. The
Plantibodies™ portfolio also has several continuation applications on
file. These applications include claims to compositions, transgenic
plants, plant cells and methods of production for:
• Single immunoglobulin molecules including single chain antibodies
• Heteromultimeric proteins not normally produced in plants
• Immunoglobulin molecules including fragments, Fab, Fab’, Fv, etc.
• Methods of passive immunization using plant made antibodies
Based on the issuance of the July 2002 patent, we believe that the
Plantibodies™ patent portfolio covers all aspects of producing any
antibody in any plant.
In addition, Biolex owns or controls nine issued U.S. patents claiming
specific pipeline antibody products and the therapeutic and diagnostic
use of immunoglobin-based targeting molecules. Biolex also has access to
a number of highly effective antibody molecules and novel technologies.
http://www.biolex.com/ip.html
------------------
Sonya PLoS Medicine
The open-access general medical journal from the Public Library of Science Inaugural issue: Autumn 2004 Share your discoveries with the world. http://www.plosmedicine.org
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