

March 16, 2010 - Fraunhofer USA CMB awarded $4.395 million for H1N1 vaccine development
DEFENSE ADVANCED RESEARCH PROJECTS AGENCY AWARDS $4.395 MILLION TO FRAUNHOFER CMB FOR H1N1 VACCINE DEVELOPMENT
NEWARK, DELAWARE -(March 16, 2010)
(Newark, Delaware) -- Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today that it has received a $4.395 million award from the Defense Advanced Research Projects Agency (DARPA) to develop a vaccine against H1N1 influenza virus using its plant based production platform.
This will be the third round of funding from DARPA and follows on CMB’s successful optimization and feasibility studies completed in 2008 and a new, state-of- the- art cGMP pilot manufacturing facility completed at the end of 2009. This current funding will allow CMB’s H1N1 vaccine candidate to progress to Phase 1 clinical trials, therefore validating the utility of the technology for manufacturing products for use in humans.
According to Dr. Vidadi Yusibov, Executive Director of Fraunhofer USA CMB, “Over the past eight years, we have taken our plant-based transient expression system for recombinant protein production from concept, through technical innovations, process improvement, and scale up. While the production platform has been validated by extensive pre-clinical studies, we are looking forward to entering the clinical phase of development.”
The need for alternative manufacturing platforms with rapid response capability became apparent in the past year with the emergence of the H1N1 influenza. DARPA’s interest in developing advanced manufacturing technologies for vaccine production stems from the need to protect military personnel and civilian populations from infections agents.
When asked their opinions on this latest announcement from Fraunhofer CMB, Members of Delaware’s Congressional delegation made the following comments.
"Fraunhofer’s work to help fight the spread of the H1N1 influenza virus is on the cutting edge of research and will impact the way we develop vaccines long-term," said Congressman Mike Castle. "Dr. Yusibov and his team are leaders in their field and we are lucky to have them here in Delaware."
“Receiving this competitive grant shows clearly that Fraunhofer is helping lead the way in creating vaccine technology that can protect us against dangerous threats such as bioterrorism and pandemic flu,” said Sens. Thomas Carper (D-Del.) and Edward (Ted) Kaufman (D-Del.). “We are proud of the work being done at Fraunhofer and look forward to seeing all that they will accomplish with this additional support from the federal government.”
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. CMB’s technology provides a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist with the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
December 18, 2009 - Award of $9.85 million from the Bill & Melinda Gates Foundation
Fraunhofer USA Center for Molecular Biotechnology Receives a Grant from the Bill & Melinda Gates Foundation for Clinical Product Development of a Malaria Vaccine
NEWARK, DELAWARE -(December 18th, 2009)
Fraunhofer USA Center for Molecular Biotechnology (CMB), announced the award of $9.85 million from the Bill & Melinda Gates Foundation for clinical development of a transmission blocking vaccine to combat malaria.
We are looking forward to beginning clinical product development following up on the exciting pre-clinical results we have achieved to date” said Dr. Vidadi Yusibov, CMB’s Executive Director. “This is one of three projects supported by the Foundation, and coupled with the Center’s cGMP (current Good Manufacturing Practice) pilot production capability will be key for the validation of CMB’s production platform.”
Dr. Philip Russell, on the Board of Trustees of the Sabin Vaccine Institute, commented, “The technology has the potential to provide the capacity and cost effectiveness required to deal with the health and economic problems caused by malaria in developing countries.”
According to The World Health Organization, 41 percent of the world's population lives in areas where malaria is transmitted, and each year more than one million people die from the disease, most of them young children in sub-Saharan Africa.
Governor Jack Markell helped announce the grant, thanking both Fraunhofer and the Gates Foundation for their efforts to improve global health. “We’re very excited that Fraunhofer’s contributions to Delaware’s legacy of innovation may save lives across the world. Their ideas and their efforts are creating the kind of quality jobs we need to move Delaware’s economy forward,” Markell said. “The Gates Foundation awards tend to honor existing excellence and potential. They found both in Fraunhofer.”
About Fraunhofer Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. CMB’s technology provides a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry.
March 10, 2009 - Research team gets $12M grant
Federal award to help Del.-based Fraunhofer develop vaccine materials
By ANDREW EDER
The News Journal
A Delaware research team has won a $12 million federal grant to develop a vaccine-production system that can respond quickly to biological threats.
The grant is the second major award this year for Fraunhofer, which announced in January that it received $8.7 million from the Bill & Melinda Gates Foundation to develop a vaccine for bird flu. Fraunhofer Executive Director Vidadi Yusibov said the research group expects to add at least 10 scientists to its staff of about 80 thanks to the grants.
The award represents the second phase of a program run by the research and development arm of the U.S. Department of Defense, which is searching for a flexible technology that can produce vaccines for threats like pandemic flu and biological weapons within weeks.
Fraunhofer Center for Molecular Biotechnology, a nonprofit research center in Newark, leads a team developing a plant-based manufacturing system. The team includes Newark biotech firm iBioPharma Inc. and Delaware State University.
Fraunhofer's technology uses tobacco plants to produce target proteins for use in vaccines. In the first phase of the program, run by the Defense Advanced Research Projects Agency, the Fraunhofer-led team proved it could produce target vaccine materials at the lab scale.
DARPA spokeswoman Jan Walker said the Fraunhofer grant is the first Phase II award under the program, although the agency expects to award additional grants. Other research groups have explored producing vaccine materials from fungi, mushrooms and crustaceans, Walker said.
Fraunhofer is building a $15 million manufacturing facility at its home in the Delaware Technology Park that is expected to be completed this summer.
The 14,000-square-foot facility, supported by a $5 million grant from the state, is designed to produce materials according to quality-control standards known as Good Manufacturing Practices (GMP), a requirement of the DARPA grant.
With the Phase II grant, the team will have a year to develop its GMP production processes before facing "live-fire" testing from DARPA. Yusibov said the agency will send Fraunhofer a vaccine target, after which the group will have three months to produce enough vaccine material for three million doses at low cost.
If successful, the Fraunhofer team could receive another grant for the third phase of the program.
Gov. Jack Markell visited Fraunhofer on Monday to congratulate employees. The governor said the award will help create good jobs and represents "exactly the kind of economic development we want" in Delaware.
"It's a reflection of the very important work that's going on here at Fraunhofer," Markell said.
March 9, 2009 - Press Release
Defense Advanced Research Projects Agency Awards $12 Million to Fraunhofer CMB and iBioPharma for Accelerated Manufacture of Biopharmaceuticals
Goal is Rapid and Economical Production of Effective Vaccines to Combat Biological Threats to Health and National Security
Newark, Delaware, March 9, 2009 -- Fraunhofer USA Center for Molecular Biotechnology (CMB) announced that the team led by CMB has been awarded Phase II funding by the Defense Advanced Research Projects Agency (DARPA) for the Accelerated Manufacture of Pharmaceuticals (AMP) program.
Phase II is a $12 million (US) initiative that will culminate with the demonstration that Fraunhofer’s proprietary plant-based manufacturing system can rapidly produce safe, effective vaccines against any rapidly emerging threat agent. In 2008, the Fraunhofer CMB AMP team successfully completed optimization and feasibility studies under the DARPA Phase I program.
The objective of the AMP program is to develop novel biological expression platforms capable of producing life-saving medical countermeasures quickly enough to be effective against rapidly emerging biological threat agents, such as pandemic flu and anthrax biological weapons. The goal of Phase II is to demonstrate the capability to generate three million doses of vaccine within twelve weeks of an outbreak at low cost using a highly resilient and controlled production platform.
Dr Michael Callahan, the DARPA Program Manager for the AMP program adds “the mission is to implement an agile, low-cost and radically accelerated subunit vaccine manufacturing platforms capable of producing emergency medical countermeasures with unprecedented purity and clinical safety.”
"Continued support from DARPA will significantly accelerate the development of our technology and address concerns facing current biopharmaceutical manufacturing, including high cost, limited capacity and time efficiency," said Dr. Vidadi Yusibov, Executive Director of CMB. "Our interdisciplinary partnership has been critical for accomplishing the goals of this project. Expertise of each of the partners in process automation (The Fraunhofer USA Center for Manufacturing Innovation), pharmaceutical process and facility engineering (AMEC Biopharmaceuticals, Inc.) and agricultural biotechnology (Delaware State University) has been instrumental for successful completion of Phase I of this project” explained Dr. Yusibov.
"CMB working with iBioPharma have developed a plant-based technology ideally suited to both commercial applications and the goals of the AMP program,” said Robert B. Kay, Chairman and CEO of iBioPharma."
Fraunhofer’s vaccine platform combines the short growing cycle of non-transgenic plants with proprietary gene expression technology to create rapid and time-efficient production of vaccine antigens. The plants, unlike traditional cells, egg and bacterial fermentation expression systems, are easily and reliably scaled-up in low cost, contained growth facilities to provide large amounts of biomass and expressed proteins within 24 days. The technology is highly flexible with the capability to design and produce vaccines in response to emerging or mutating virus strains.
About iBioPharma, Inc.
iBioPharma (OTCBB:IBPM) is a biopharmaceutical company focused on vaccines and therapeutic antibodies developed and produced using its proprietary plant-based technologies. Further information is available at www.ibiopharma.com.
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. CMB’s technology provides a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist with the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
This document was cleared by DARPA on February 24, 2009. Distribution Statement A: Approved for Public Release, Distribution Unlimited.
March 2, 2009 - Fraunhofer Center for Molecular Biotechnology Summer Internship Program
Deadline: March 30, 2009
Several positions are available for summer internships at the Fraunhofer Center for Molecular Biotechnology in Newark, Delaware. Applicants who have completed their sophomore year in one of the following disciplines are eligible to apply:
Biology
Biochemistry
Molecular Biology
Microbiology
Required Experience:
Experience in basic biochemical and molecular biology laboratory skills, such as micro-pipetting, electrophoresis equipment, balances, stir plates and pH meters, etc. Experience with microbial aseptic techniques.
Other life science majors will be considered if applicant can demonstrate relevant experience.
Advanced course work in cell or molecular biology is a plus.
Internships will start either June 1 or June 15 and run for ten weeks. Interns must be able to start on one of those two dates to participate in scheduled safety training.
All interns will be paid $400/week
Please submit resume and cover letter indicating your interest in the internship to:
dervin@fraunhofer-cmb.org
Deadline for application is March 30, 2009
Interviews for selected applicants will be scheduled during April 6-17
March 2, 2009 - Governor Minner Biotechnology Scholarship
Deadline: April 15, 2009
Eligibility: Must be planning to obtain a degree or certificate in the biotech field from the University of Delaware, Delaware State University or Delaware Technical & Community College. Must demonstrate excellent grades in academic courses, including basic science courses and relevant specialized courses. Preference is given to students that are Delaware residents; however, students who are not Delaware residents may apply.
Award: Scholarships of up to $3,500 each will be awarded to students attending each of the three eligible institutions. The type and amount of aid shall be at the discretion of the Board of Directors of the Delaware Community Foundation.
Contact: Beginning in February 2009, applications may be downloaded or posted online via this website. For more information, please contact your guidance counselor, college or university department chair or Richard Gentsch at the Delaware Community Foundation 302-504-5222.
January 30, 2009 - $8.7 million bolsters bird-flu battle
Newark biotech firm receives Gates grant
By ANDREW EDER
The News Journal
A nonprofit research group in Newark has received an $8.7 million grant from the nation's largest
foundation to continue development of a plant-based vaccine for bird flu.
The Fraunhofer Center for Molecular Biotechnology expects to add at least 10 Ph.D.-level scientists
to its staff of 80 to help move its vaccine candidate toward clinical trials in humans.
The grant builds on a $2.6 million award to Fraunhofer two years ago from the Bill & Melinda Gates
Foundation to find potential flu vaccines.
Vidadi Yusibov, Fraunhofer's executive director, said the latest grant shows the foundation believes
Fraunhofer's technology -- which makes vaccine materials by coaxing plants into producing certain
proteins -- can yield commercially viable vaccines.
The grant "will help us to establish all the processes of making a suitable product you can take into
human trials," Yusibov said.
Avian influenza, or bird flu, is a contagious disease that has largely been confined to animals. The
World Health Organization has tracked 403 human cases of a virulent flu strain known as H5N1,
resulting in 254 deaths, most of those in Asia.
But the WHO warns that the virus could mutate and become as contagious as normal influenza,
causing a pandemic of widespread illness and millions of deaths worldwide. China has reported three
cases of H5N1 infection this month in humans, resulting in two deaths so far.
The Fraunhofer research is targeting the H5N1 virus, and the group is working with commercial
partner iBioPharma Inc., a Newark biotech firm that has an exclusive license on Fraunhofer's plantbased
technology.
Fraunhofer has also worked with the Gates Foundation to develop vaccines for sleeping sickness and
malaria, which afflict the developing world.
"It is essential that new vaccines reach the people who need them most," said Doug Holtzman, senior
program officer for the Gates Foundation. "If successful, this project could help developing countries
respond quickly to outbreaks of influenza and other infectious diseases to significantly limit their
impact on vulnerable populations."
Yusibov said Fraunhofer will seek Food and Drug Administration guidance on conducting toxicity
studies in animals for its vaccine candidate. Fraunhofer would use data from those studies to submit
an investigational new drug application with the FDA.
If the application is approved, Fraunhofer could begin Phase 1 trials to test the vaccine candidate's
safety in humans. Yusibov said he expected the Gates Foundation grant to carry development to the
end of Phase 1 trials, after which the research partners would look for a larger commercial partner
with vaccine development experience to help take the product to market.
Fraunhofer, aided by a $5 million grant from the state, is building a 14,000-square-foot pilot-scale
production facility to produce material for clinical trials at its home in the Delaware Technology Park.
Yusibov said the facility should be complete by June. Fraunhofer is now looking to hire at least 10
engineers and scientists.
"We have a very talented R and D staff," Yusibov said, "but now we need to bring the people who are
experienced in clinical development."
January 29, 2009 - Press Release
Fraunhofer USA Center for Molecular Biotechnology Receives $8.7 million from Gates Foundation for Avian Influenza Vaccine Development
Contact: Vidadi Yusibov, Ph.D. 302-369-3034
NEWARK, DELAWARE, January 29, 2009. The Center for Molecular Biotechnology (CMB) has received an $8.7 million grant from the Bill & Melinda Gates Foundation to support continued development of an avian influenza vaccine that uses transient plant-based technology. CMB will develop vaccines against highly pathogenic avian influenza viruses of H5N1 subtype, and work to advance promising candidates into clinical trials.
Dr. Vidadi Yusibov, CMB’s Executive Director said, “CMB’s vaccine technology has the potential to revolutionize how vaccines are manufactured, allowing for a more rapid and affordable response to pandemic flu threats.”
“It is essential that new vaccines reach the people who need them most,” said Doug Holtzman, Senior Program Officer for the Bill & Melinda Gates Foundation. “If successful, this project could help developing countries respond quickly to outbreaks of influenza and other infectious diseases to significantly limit their impact on vulnerable populations.”
CMB’s platform provides a new alternative to traditional vaccine production, with improved speed, surge capacity, and cost efficiency. The technology has also earned support from the Defense Advanced Research Projects Agency (DARPA) to continue developing the technology and establish it as a platform for accelerated manufacturing pharmaceuticals. The transient plant-based expression technology is licensed by CMB from its partner, iBioPharma, Inc.
About Fraunhofer Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. CMB’s technology provides a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry.
October 5, 2008 - Partnerships touted for work with vaccines
Del.'s biotechnology industry showcased at conference
By ANDREW EDER
The News Journal
As researchers turn to plants, insects, stem cells and other building
blocks to produce new vaccines, partnerships will be critical in
pushing the technologies to market.
The effort got a boost last week during a four-day conference in
Wilmington. The meeting, titled "New Cells for New Vaccines
III: From Lab Bench to Clinical Trials," brought together about
140 attendees from 10 countries at the Hotel du Pont last Sunday
through Wednesday.
The conference included representatives from universities, governments,
foundations, nongovernmental organizations, independent research
labs and the pharmaceutical and biotechnology industries.
Conference participants said each sector has a role to play as researchers
look beyond the traditional method of vaccine development -- growing
a virus in chicken eggs -- to find new solutions for pandemic flu,
malaria, HIV and a host of other global public health challenges.
"There is no organization on this planet, no government, that
can take care of this problem on its own," Douglas Holtzman,
senior program officer for the Bill & Melinda Gates Foundation,
said during a presentation Tuesday morning.
The vaccine conference was organized and sponsored by two Newark
companies -- Fraunhofer Center for Molecular Biotechnology, a nonprofit
research group, and iBioPharma Inc., a company developing vaccine
candidates using a plant-based technology purchased from Fraunhofer.
The Delaware Economic Development Office also was a sponsor.
Vidadi Yusibov, executive director of Fraunhofer, said the conference
was helpful in exposing Delaware's biotechnology industry to a wider
audience. This was the event's third year, and its second in Wilmington.
Fraunhofer collaborates on vaccine-related projects with universities,
foundations and governments around the world. For example, Holtzman
detailed one of the Gates Foundation's projects, an effort to develop
a vaccine for African trypanosomiasis -- also known as sleeping
sickness -- in cattle. In addition to Fraunhofer, the project included
collaborators from Makerere University in Uganda and McGill University
in Montreal.
The Seattle-based foundation, started by the Microsoft founder and
his wife, has a goal of preventing 4 million deaths a year by increasing
the use of existing vaccines and introducing new ones. The foundation
has donated nearly $2 billion since 1998 to vaccine development
efforts.
"Meetings like this are very fertile ground for identifying
collaborators and innovations," Holtzman said on the sidelines
of the conference.
Yusibov said the global network of companies, governments, universities
and foundations involved in vaccine development illustrates how complex
the task is, since the origins of diseases -- and the greatest market opportunities
-- are often found in the poorest parts of the world.
"The diseases do not necessarily occur here," Yusibov
said. "We need to look at the global picture."
Fraunhofer, aided by a $5 million grant from the state, is building
a 14,000-squarefoot pilot-scale production facility to produce material for clinical
trials at its home in the Delaware Technology Park.
Fraunhofer's technology works by introducing an antigen -- a substance
that provokes a response from the body's immune system -- into a molecular
vehicle known as a "launch vector."

Ornkleaw Zepp, a research assistant at
Fraunhofer Center for Molecular
Biotechnology, rinses plants that have
gone through a process called vacuum
infiltration that places bacteria into the
plants.
The launch vectors, carrying the antigen's genetic code, are introduced
into bacteria, where they multiply rapidly. Tobacco plants are then dunked into a solution containing the bacteria, which enter
the plants through a process called vacuum infiltration.

Plants containing a target protein are
harvested and ground up to extract it.
The material is purified to be used in
producing a vaccine.
Inside the plant, the genetic material multiplies rapidly, producing
the target protein. Within a week, the plants are harvested and ground up to extract the protein, which is further purified into
material suitable for a vaccine.

Hassane Elhassani, a lab technician at
Fraunhofer Center for Molecular Biology in
Newark, checks plants in a recovery room after
they were infiltrated with bacteria.
IBioPharma, which recently spun off from a parent company and changed
its name from InB:Biotechnologies, entered into a deal with Fraunhofer
in 2004 to acquire the nonprofit's technology. The six-employee company
announced last month that it has chosen a plant-made flu vaccine as
its first candidate for clinical development in humans.
Jennifer Kmiec, vice president for business development and marketing
for iBioPharma, said the plant-based process offers the potential to produce a large amount of vaccine in a shorter period
of time than the traditional method of cultivating vaccines in chicken eggs. Such "surge capacity" could be critical
in responding to a flu pandemic.
IBioPharma hopes to submit an investigational new drug application
with the U.S. Food and Drug Administration in the second quarter of 2009, a step needed to begin clinical trials in humans.
Kmiec said the company would like to get its vaccine through the first of three stages of clinical trials before seeking a larger
pharmaceutical or biotechnology company as a development partner.
"The further we can take it, the more value we can offer to
a partner," Kmiec said.
For iBioPharma, Kmiec said, the vaccine conference offered a chance
to find business development opportunities and get its name out in front of prominent researchers and companies in the vaccine
field.
Conference organizers also said the presence of the FDA was crucial
as researchers work to produce vaccines using cells not just from plants, but also algae, bacteria, mushrooms and other organisms.
For example, Savage, Md.-based Chesapeake PERL, which has a lab in Newark, is working to develop a smallpox vaccine using
insect larvae from moths.
Fraunhofer's Yusibov said the industry needs to work hand-in-hand
with regulatory agencies to prepare them for new vaccines in development.
"There's this jungle of new technologies coming and we're going
to be knocking on your door," Yusibov said. "Are you ready?"
September 22, 2008 - New Cells for New Vaccines
III Press Release
International Scientific Conference Features
Advances in Vaccine Development and Disease Prevention
(Newark, DE) –– Leading scientists from around the
world will meet in Wilmington, Delaware at the Hotel du Pont, September
28 - October 1, 2008, to exchange information on innovative approaches
for producing life-saving vaccines and antibodies to combat and
prevent infectious disease epidemics worldwide.
More than 150 scientists and business leaders in the biotechnology
and pharmaceutical industries will convene for the New Cells for
New Vaccines III: From Lab Bench to Clinical Trials third annual
international scientific conference. The event is organized by the
Fraunhofer USA Center for Molecular Biotechnology (under the auspices
of the International Association for Biologicals–IABS, headquartered
in Geneva, Switzerland) and iBioPharma, Inc., both located at the
Delaware Technology Park in Newark, Delaware.
“With threats of influenza pandemic and bio-terror agents,
there is urgent global need to develop countermeasures against disease
pathogens,” explained Vidadi Yusibov, Ph.D., Executive Director
of the Fraunhofer USA Center for Molecular Biotechnology (CMB).
Dr. Yusibov noted that over the past 50 years, there has been a
dramatic increase in the types of cells that can be used for vaccine
and antibody production. “However, there remains a need for
new cell substrates that can provide safer, faster and more cost
effective production alternatives to current techniques, especially
given the inherent problems in existing vaccine development technologies,”
Dr. Yusibov said.
“A key aspect of the success and viability of a vaccine
development project is the choice of an appropriate cell substrate,”
said Geoffrey Schild, Ph.D., Chief Scientific Officer, iBioPharma,
Inc., and Chair of the International Society for Influenza and other
Respiratory Virus Diseases. Dr. Schild currently leads iBioPharma’s
development of vaccines and drugs by producing proteins in plants,
using a technology developed by the nonprofit Fraunhofer USA CMB.
“The advantages of plant, animal and insect cell systems for
vaccine production is recognized internationally with many projects
in progress,” Dr. Schild said. These projects include development
of respiratory virus, cervical cancer, anthrax and malaria vaccines,
as well as therapeutic antibodies to treat influenza infections.
The four-day program includes 11 topic areas, with multiple sessions
covering new substrates for vaccine development through clinical
trial case studies. Renowned scientists and keynote speakers include:
Thomas Monath, M.D., Partner, Pandemic and Biodefense Fund, Kleiner
Perkins Caufield & Byers (USA), has published over 340 papers
and edited 6 books on the epidemiology, immunology and pathogenesis
of viruses and vaccine development;
Sir John Skehel, Ph.D., of the National Institute for Medical Research
(UK), is one of the world’s leading virologists and, most
recently, a joint recipient of the 2007 International Louis D, Institut
de France Grand Prize for research devoted to the fight against
the transmission of diseases from animals to man;
Douglas Holtzman, M.D., Senior Program Officer, Bill & Melinda
Gates Foundation (USA), the largest private foundation in the world
with a global focus to enhance healthcare and reduce extreme poverty;
Peter Hotez M.D., Ph.D., President, Sabin Vaccine Institute and
Walter G. Ross Professor & Chair, Department of Microbiology,
Immunology & Tropical Medicine, The George Washington University
(USA), where his major research and academic interests are in neglected
tropical disease control and vaccine development;
Lars R. Haaheim. Ph.D., Professor, Influenza Centre, University
of Bergen, Department of Microbiology & Immunology, The Gade
Institute (Norway), where he leads extensive studies on the precise
kinetics of the post-vaccination humoral and cellular immune response,
as well as mucosal immunity. He currently serves on the Norwegian
Influenza Pandemic Preparedness Committee and was actively involved
in preparing the first WHO Influenza Pandemic Preparedness Plan;
and
Suresh Jadhav, Ph.D., Executive Director, Quality Assurance &
Regulatory Affairs, Serum Institute of India, Ltd., and President
of the Developing Countries Vaccine Manufacturers’ Network
(India), a voluntary public health driven alliance of vaccine manufacturers
from developing countries with a goal to provide quality vaccines
at affordable prices to the emerging world.
Attendees of the conference will include distinguished scientists
and business leaders who are involved in vaccine development and
production, as well as public health officials, academic scientists,
and medical and veterinary experts.
A complete agenda and registration information are available online
at www.NewCellsforNewVaccines.com
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit
research organization whose mission is to develop safe and effective
vaccines targeting infectious diseases and autoimmune disorders.
CMB’s technology provides a safe, rapid and economical alternative
for vaccine production. The Center conducts research in the area
of plant biotechnology, utilizing new, cutting edge technologies
to assist the diagnosis, prevention and treatment of human and animal
diseases. The Center houses individuals with expertise and excellence
in plant virology, pathology, molecular biology, immunology, vaccinology,
protein engineering, and biochemistry.
Fraunhofer USA, Inc. is a subsidiary of Fraunhofer Gesellschaft,
Europe’s largest organization for applied research. Further
information is available at www.fraunhofer-cmb.org.
For press registration to attend the workshop or for additional
information, contact: Dale Ervin, Fraunhofer USA CMB at 302-369-3034
or dervin@fraunhofer-cmb.org
February 21, 2008 - 2008 Governor Minner Scholarship Fundraiser Dinner
Where: Caffe Gelato - Newark, DE
When: Sunday, April 27 (Seating at 5:00 PM)
2008 Governor Minner Scholarship Fundraiser Dinner Flyer
The fund was started by Fraunhofer Center for Molecular Biotechnology in 2006 to provide support for local students pursuing careers in biotechnology at the University of Delaware, Delaware State University and Delaware Technical and Community College. This spring, the fund will make awards to the third group of students.
While Fraunhofer CMB started the scholarship fund, several other local companies including Astra Zeneca, Quest Pharmaceuticals, InB Biotechnologies and Strategic Diagnostics have also been major contributors. All of these companies and many more like them have a growing need for qualified researchers and scientists. The scholarship fund helps encourage local students to consider careers in the growing area of biotechnology, thus enabling local companies to hire local talent.
The fund is held and administered by the Delaware Community Foundation.
January 11, 2008 - Facility seeks new anthrax vaccine
Biotech aims to produce medicine from plants
If a large-scale anthrax attack strikes a big U.S. city a decade from now, citizens could be protected because of the work of a local nonprofit to develop a plant-based vaccine.
The Fraunhofer USA Center for Molecular Biotechnology is the only facility in the United States using plants that have not been genetically modified to make vaccines to protect people from agents such as anthrax or the plague.
The scientific nonprofit, in Newark's Delaware Technology Park, is trying to develop the first plant-based vaccine, which would have the advantage of a production time of six to seven weeks. Current vaccine production require six or more months.
"The stockpiling capacity will be much more flexible and we will be able to make enough of this vaccine for emergency situations," said Vidadi Yusibov, executive director of the Fraunhofer center.
Sen. Tom Carper and Rep. Mike Castle toured the facility Thursday morning to see how the vaccine is processed. Both have helped bring in millions of federal research dollars to help pay for the research.
The nonprofit recently received $4 million from the Department of Defense to pursue clinical trials of the vaccines in humans once they are approved by the U.S. Food and Drug Administration. Fraunhofer also has received about $20 million in other federal and private grants to help fund research and development, Yusibov said.
Fraunhofer researchers are already working on vaccines for a host of other diseases, including malaria and cancer.
Fraunhofer USA is a subsidiary of Fraunhofer-Gesellschaft, a giant scientific private foundation based in Munich, Germany.
Castle said the research can lead to protection for U.S. soldiers.
"Hopefully, it will allow these vaccines to be produced faster in the event of a bioterrorism attack," he said. "Vaccinations will help our men and women in the military serving in harm's way."
Inside a climate-controlled greenhouse at the facility, tobacco plants are grown to maturity in five weeks.
"Tobacco plants are very good at generating a lot of leaf tissue and they grow fast," Yusibov said. "It's also the best host for the vector that produces the vaccine."
The plants are then placed inside a vacuum chamber where a bacterium is infused into the plants. From there, the plants are placed in another climate-controlled greenhouse to grow for a week.
Using the DNA from the bacteria, the plants make the proteins that comprise the vaccine. They are then harvested and the proteins are purified.
The environment is safe for researchers.
"We have nothing here that can be hazardous to humans," Yusibov said. "We're not using any anthrax bacteria or influenza viruses. What we're using is completely harmless to humans as a process."
Fraunhofer has been working on the vaccine for almost four years. The local operation has grown to 60 employees from two in July 2001.
Yusibov said that if the vaccines for anthrax and the plague are successful, there's a good chance that a similar method will be used to produce a vaccine to fight bird flu and other infectious diseases. The current method, using eggs, takes about six months.
But before the vaccine is ready for public use, it must first go through three phases of clinical trials. Many vaccines that protected primates in studies did not show the same success in humans.
The plant-based vaccine was shown to protect primates exposed to anthrax.
"It's not guaranteed that everything that will work in animals will work in humans," Yusibov said.
He expects that it will take about five years before the vaccine is ready for the public.
Article Text: By HIRAN RATNAYAKE, The News Journal
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