Transcript Breakout 1: Eastern Asia

Session #1: Paths From
Assessments to Functional Labs
• Examples of how countries and companies
construct labs in three regions
• Activities at those labs
• Effectiveness of the labs to meet their
original objective
• Lessons learned during lab operation
Rapporteurs: Fran Sharples, Ben Rusek, and Alison Hottes
Breakout #1: Eastern Asia
Fran Sharples
NAS Staff
Mahidol Oxford Tropical Medicine Research
Unit (MORU)
• Major labs in Bangkok, Vientiane
• MORU funding imperative is to follow BMBL5, US Select Agent
rules, Thai law
• Requires full time biosafety administrator, registered biosafety
professional, 7 biosafety site representatives
• Requires robust induction procedure and documented competency;
dual use awareness; training by experts with regular refreshers
• Had to create baseline inventory, have catalogued 20,000 samples
from freezers over last 3 years
• Need to rethink some aspects, e.g., in tropical climate, wasteful to
pump cool, dry air outside
• Engineering and technology choices should be based on risk
assessments: Is BSL3 really needed? Could BSL2 with some upgrades
work instead?
International Vaccine Institute,
South Korea
•
•
•
•
•
•
•
•
•
Non-profit international with HQ in Seoul under UN Develop Program
Subject to Korean law on highly dangerous pathogens
Construction began 2007, certified by Korean CDC in 2009, opened in 2010,
has operated for one year
Operates under internal regulations in BSL3 manual and 19 SOPs
Internal approval system: Institutional Biosafety Committee for research and
General Manager for access
Training to create and nurture biosafety culture for both lab workers aqnd
maintenance staff
Maintenance: daily/weekly/monthly/annual inspections
Alarm system to detect malfunction emergencies
Annual revalidation in 2011
Central Biocontainment
Laboratory, Bangkok, Thailand
• Supported by University medical centers and Thai Red
Cross
• Need to provide safe environment for working with
bioagents (SARS, bird flu, swine flu)
• Operated since 2008
• Working group of 5 experienced members, one full time
staff for facility and equipment, regular maintenance
• Efforts to sustain and improve
• Obstacles: costs very high, supported by faculty of
medicine so far
Conclusion
• East Asia a hotbed of emerging and re-emerging infectious
diseases
• At least 45 BSL3 LABS in southeast Asia
• Many east Asian countries low resource settings: Laos,
Cambodia, Vietnam, Thailand
• For many labs in these countries, are questions about
standards, management, training, security, lack of
biosafety professionals, etc.
• Many also lack national legislation or have laws that are
poorly enforced and/or understood. (Does not apply to
Singapore, Korea, some Thai law).
• Money to build labs is easy, money for maintenance is
hard to come by.
Breakout #2: Africa
Ben Rusek
NAS Staff
Veterinary Serum and Vaccine
Research Institute (VSVRI)
• Located in Cairo, Egypt
• Vaccine production facility for avian flu, FMD, sera and
diagnostic reagents and research in these areas
• Part of the response to the Egyptian avian flu outbreak
• Created BSL3 lab out of existing lab due to the difficulty
of getting a license for a new site, construction will be
complete in three months
• Will be a fully functional BSL3 facility when online
• Currently developing biosafety training program for lab
workers
Morocco Biopharma Research Lab
• State lab created in 1984. Used for bacterial fermentation,
diagnostics and animal disease surveillance, vaccine production,
and culture collection.
• Has helped keep Morocco free from FMD since 1998 although
FMD is endemic in the region (maintains 2 million doses as
concentrated inactivated antigen that could be manufactured
within two days).
• Plans to upgrade to GMP standards to improve production and
quality control and expand the facilities at the current location
• This would include an upgrade to the lab buildings from
centralized to terminal HEPA filters and improve fluid
distribution and waste treatment.
• Eventually build a new laboratory according to international
standards away from the current residential area location.
The International Centre of Medical
Research of Franceville Gabon: CIRMF
• Primarily gov funded lab has isolated 16 of 18 strains of
Ebola
• CIRMF remote location is close to emerging infections
(500 km from capital, all facilities onsite)
• Emergency BSL3+ took 2 years to build in 1997 after
Ebola outbreak in Gabon, BSL4 completed in 2011 and
took 7 years
• Today operates BSL3, ABSL3 and primate facility and
BSL4 glovebox
• Remote location makes maintenance a problem
Conclusion
• North Africa is an international crossroads and Central Africa is
a hotbed of emerging infectious diseases so the location of
containment labs in the region is especially important
• Although the three labs presented in Egypt, Morocco and Gabon
would be considered to be in “developing” countries all are well
funded
• For these labs partnership with other countries and federal
sponsorship are important for sustainment
• These labs are fulfilling their research and public health goals
but require good leadership to implement projects and programs
in the future.
• Again largest issues are funding for maintenance and training.
Important to design the maintenance plan for a facility as it is
being designed and built
• Might be useful to have a group that certifies BSL3 equipment
in Africa
Breakout #3: Eastern Europe and
Western Asia
Alison Hottes
NAS Staff
Pendik Veterinary Control and
Research Institute (Turkey)
• Founded in 1894 and moved to current location in 1912
• Started by producing cattle plague serum
• Currently national reference lab for some animal diseases
and has responsibility for animal diseases in local region
• Produces vaccines, serums, antigens
• In response to avian influenza in domestic and wild
poultry, Turkey assessed needs
– Decided to add BSL3 capabilities to Pendik
• Currently waiting for equipment placement and
personnel training
Chumakov Institute of Poliomyelitis
& Viral Encephalitides
of Russian Academy of Medical Sciences
• Founded 1955 to combat poliomyelitis
– Produced vaccines that lead to successful eradiation of
poliomyelitis in Russia (since reintroduced)
• Focus changing to match current public health threats such
as hepatitis B and hemorrhagic fever with renal syndrome
• Recently removed old infrastructure and updated virus
collections
• Currently holds Containment BSL2 Certification (Russian
system)—need to pay to maintain certification
• 6 workers, including presenter, have been infected by a
hantavirus or an arenavirus during laboratory research
Georgian Central Public Health
Reference Laboratory
• U.S. supporting as part of Biological Threat Reduction
Program and will maintain long-term presence
• Will serve as regional reference lab
– Promote public and animal health through infectious disease
detection, epidemiological surveillance, and research for the
benefit of Georgia, the Caucasus region, and the global
community.
•
•
•
•
Half BSL3-capable, half BSL2-capable
Animal and human wings
Currently training Georgian locals
Expect certification by end of the year
Planned Kyrgyz Republic Lab
• Canada committed $1 billion to Global Partnership including $100
million for biological non-proliferation
• Searched for projects in former Soviet Union with large impact
– Kyrgyz Republic has endemic diseases of terrorist concern (e.g., FMD,
anthrax), large pathogen collections, and decaying facilities
• Designed lab
–
–
–
–
Animal and human facilities
Central reference lab
Attempt to use local markets and trades
Involved scientists, government, community, and designers from the
beginning
• Lab currently on hold due to Krygyz Republic politics
Lessons Learned
• Uncertainty leads to overdesign do full needs
assessment first and expect things to evolve
• Involve and inform everyone from the start
including community, local and national
government, collaborators, scientists, designers,
engineers, contractors, and certifiers
• Only accept contractors and sub-contractors with
containment lab experience
Issues Raised
• When should pathogen collections be destroyed?
Preserved?
• Should the decision to build a lab be a national or
international decision?
• Is there a way to certify workers as BSL3competent?
• Should animal and human work be combined in a
single lab?
– Cost effective
– Groups historically are separate, but forced interactions
can be productive (One Health)