IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org
Alejandro Ortega-Beltran
Plant Pathologist
On behalf of the Aflasafe Team
4 November 2019
Aflasafe Technology
Advancements
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
The problem
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Crops always become associated
with Aspergillus fungi
1 – >1,000,000
Propagules / g
Aspergillus and crops
The most potent carcinogen found in nature
Contamination impacts Health, Income, Trade
Aflatoxin content range (ppb)
0 – 20
21 – >48,000
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aspergillus and crops
137 ppb 179 ppb182 ppb 2 ppb
Bamako, Mali, 25 October 2019
5,000,000
CFU/g
7,000
CFU/g
250,000
CFU/g
2,000
CFU/g
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Mali, 10 December 2017
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Senegal, 6 October 2018
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
The solution
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflatoxin-producing fungi
Other Aspergillus species
Thousands of genotypes
Vegetative Compatibility Groups (VCGs)
Aspergillus flavus
Influenced by
cropping systems,
climate, elevation,
rainfall, insects..
Aflatoxin biosynthesis genes
Atoxigenic fungi exist
in all regions of the
world and can be used
as biocontrol agents
0
1
2
3
4
5
A B C D E F
Logaflatoxinppb
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Example of Ghana
Maize = 326
Groundnut = 183
Number of samples
Superior strains (highly
adapted, with wide
distribution, defective
aflatoxin genes) were
selected for field efficacy
trials in Ghana
Candidate strains
Toxin producers: 4,178
Atoxigenic: 905
Toxigenicity
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflasafe composition
Aflasafe ingredients
Finished product
Product in the field
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Non-treated field Treated field
Aflasafe mode of action
Treated
6,000
17,000
85,000
65,000
Control
7,000
14,000
75,000
95,000
Fungal densities
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Non-treated
Aflasafe-
treated
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflatoxin reductions
Results from >1,500 fields
90%: <4 ppb
7-8%: 5 – 20 ppb
2-3%: >20 ppb
vs
>20, >100, >1,000 ppb
Treated vs non-treated
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Integrated management strategy
Optimal
storage
Rapid grain
drying
Timely
harvest
Sorting and
processing
Awareness
Policies
Testing
Dietary
interventions
Market
development
Resistant
varieties
Insect
control
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Registration of
biocontrol
products
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
A member of the CGIAR Consortium www.iita.org
Headquarters
PMB 5320, Oyo Road, Idi-Oshe
Ibadan, Nigeria
Tel.: +1 201 6336094,
+234 2 7517472,
Fax.: +44 (208) 711 3786 (via UK)
International mailing address
IITA, Carolyn House, 26 Dingwall Road
Croydon CR9 3EE, UK
aflasafe™ Demonstration Scale Plant SOP’s for:
1. Raw material intake/ Sorghum grading.
2. Production - Spore production.
3. Production - Substrate production.
4. Quality control.
5. Maintenance.
6. Cleaning.
7. Water treatment and analysis
Registration in Nigeria
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Summary of toxicological studies
Study Type AF36 aflaguard aflasafe™
aflasafe
KE01
aflasafe
SN01
aflasafe
BF01
aflasafe GH01
and GH02
aflasafe
TZ01
and TZ02
aflasafe ZM01
and ZM02
aflasafe
MWMZ01
and MZ02
Acute oral
Study, no
adverse
Study, no
adverse
Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Acute dermal Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Acute eye
Waived
Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Acute
Inhalation
Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Pulmonary
Study, no
adverse
Study, no
adverse
Waived Waived Waived Waived Waived Waived Waived Waived
Injection Waived
Study, no
adverse
Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Hypersensitivity Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Immunotoxicity Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Tier 2 and 3 Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Summary of eco-toxicological studies
Study Type AF36 aflaguard aflasafe™
aflasafe
KE01
aflasafe
SN01
aflasafe
BF01
aflasafe GH01
and GH02
aflasafe
TZ01
and TZ02
aflasafe ZM01
and ZM02
aflasafe
MWMZ01
and MZ02
Avian
Injection
Study, no
adverse
Study, no
adverse
Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Wild mammal Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived
Beneficial
Insect
Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived
Honeybee
Study, no
adverse
Study, no
adverse
Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Avian oral Waived
Study, no
adverse
Study, no
adverse
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Fresh fish &
invertebrates
Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Algae Waived Waived Waived
Study, no
adverse
Waived Waived Waived Waived Waived Waived
Non target
plants
Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflasafe manufacturing
From the laboratory to
the industrial process
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Soak in water 2 hr
Autoclave 45 min @ 121 ° C
Soak 5 min in spore suspension
Incubate 18hr @ 31°C
Oven drying 4 days @ 50 ° C
Packaging
Clean white sorghum
QC
1
2
3 4
5
6
7
300 kg/week Aflasafe
production at Food & Nutrition
Sciences Lab IITA
Laboratory production
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Industrial production
Aflasafe factory and laboratory in Ibadan
Kaolack, Senegal
Started producing in
June 2019
Katumani, Kenya
Operational since
Dec 2017
KALRO-Katumani
BAMTAARE
Factories for Tanzania, Rwanda, and Mozambique being
constructed or planned as of now
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Production of inoculum
Requirements:
• Highly-qualified staff
• Special laboratory
• Rigorous quality control procedures
• Tight schedule
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Dry inoculum
• Shelf life: 3 months*
• Reduced contamination risks
• Elimination of one laboratory
• Uniformity of product quality across
countries
New process – needs to be
refined, optimized, and
industrialized
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Research – Development – Commercialization (Delivery)
Develop
baseline data
on aflatoxin
prevalence
Find
native
candidate
atoxigenic
strains
Field
efficacy
trials /
enhance
local
research
capacity
Gain regulatory
approval /
enhance capacity
of local regulator
Conduct market
analysis,
elaborate
commercializatio
n options
Mobilization of
private sector,
selection of
manufacturer and/or
distributer partners,
awareness raising
Test the market
with investor,
conduct large-
scale
demonstration
and awareness
raising
Work with
investors to
manufacture,
distribute and
build awareness,
improve the
product
Research for Development Partnership for Delivery (Commercialization)
1 2 3 4 5 6 7 8
Pathway for Scale-Up
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Demonstrations on-site
Test the market, conduct
large-scale demonstration
and awareness raising`
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
SDGs
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflasafe:
a highly effective
technology, but….
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Bridging knowledge gaps for improved understanding of aflatoxin biocontrol to
guide enhanced performance of biocontrol products
• What is the influence of intercropping on efficacy?
• Does pesticide use have influence on product performance?
• Does application of Aflasafe have influence on soil biological processes and
other toxigenic fungi?
• Does Aflasafe application influence occurrence of mycotoxins other than
aflatoxin?
• When is the appropriate time for application of Aflasafe? What is the optimum
dose for field application?
• What is the optimum rate of application if some inoculum is carried over to the
next season after application?
• What impact will climate change have on product performance?
• What are the advantages offered by selection of widely-distributed strains for
constituting biocontrol products over strains with high local occurrence?
• Does a multi-strain product offer significant benefit over single strain product?
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Bridging knowledge gaps for improved understanding of aflatoxin biocontrol to
guide enhanced performance of biocontrol products
• Would a two-strain product be effective?
• What are the benefits, if any, of area-wide treatment with biocontrol agents?
• What approaches should be explored to improve product performance under
extended drought?
• How can loss of inoculum in the field be reduced from granivores?
• What alternate carriers (the current carrier is heat-killed sorghum grain) can
be used to reduce cost and increase effectiveness?
• What changes in Aflasafe manufacturing processes are possible to improve
manufacturing efficiency at different scales?
• What are the incremental benefits of integrating various aflatoxin
management practices with Aflasafe?
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Joint Effort
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Questions?
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Mali, 10 December 2017
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
A. flavus L morphotype
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Aflatoxin production ability
IITA is a member of the CGIAR System Organization.
www.iita.org | www.cgiar.org
Communities’ composition

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A4A2019 Session 4: Aflasafe technology advancements

  • 1. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Alejandro Ortega-Beltran Plant Pathologist On behalf of the Aflasafe Team 4 November 2019 Aflasafe Technology Advancements
  • 2. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org The problem
  • 3. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Crops always become associated with Aspergillus fungi 1 – >1,000,000 Propagules / g Aspergillus and crops The most potent carcinogen found in nature Contamination impacts Health, Income, Trade Aflatoxin content range (ppb) 0 – 20 21 – >48,000
  • 4. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aspergillus and crops 137 ppb 179 ppb182 ppb 2 ppb Bamako, Mali, 25 October 2019 5,000,000 CFU/g 7,000 CFU/g 250,000 CFU/g 2,000 CFU/g
  • 5. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Mali, 10 December 2017
  • 6. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Senegal, 6 October 2018
  • 7. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org The solution
  • 8. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflatoxin-producing fungi Other Aspergillus species Thousands of genotypes Vegetative Compatibility Groups (VCGs) Aspergillus flavus Influenced by cropping systems, climate, elevation, rainfall, insects.. Aflatoxin biosynthesis genes Atoxigenic fungi exist in all regions of the world and can be used as biocontrol agents 0 1 2 3 4 5 A B C D E F Logaflatoxinppb
  • 9. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Example of Ghana Maize = 326 Groundnut = 183 Number of samples Superior strains (highly adapted, with wide distribution, defective aflatoxin genes) were selected for field efficacy trials in Ghana Candidate strains Toxin producers: 4,178 Atoxigenic: 905 Toxigenicity
  • 10. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflasafe composition Aflasafe ingredients Finished product Product in the field
  • 11. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Non-treated field Treated field Aflasafe mode of action Treated 6,000 17,000 85,000 65,000 Control 7,000 14,000 75,000 95,000 Fungal densities
  • 12. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Non-treated Aflasafe- treated
  • 13. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflatoxin reductions Results from >1,500 fields 90%: <4 ppb 7-8%: 5 – 20 ppb 2-3%: >20 ppb vs >20, >100, >1,000 ppb Treated vs non-treated
  • 14. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Integrated management strategy Optimal storage Rapid grain drying Timely harvest Sorting and processing Awareness Policies Testing Dietary interventions Market development Resistant varieties Insect control
  • 15. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Registration of biocontrol products
  • 16. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org A member of the CGIAR Consortium www.iita.org Headquarters PMB 5320, Oyo Road, Idi-Oshe Ibadan, Nigeria Tel.: +1 201 6336094, +234 2 7517472, Fax.: +44 (208) 711 3786 (via UK) International mailing address IITA, Carolyn House, 26 Dingwall Road Croydon CR9 3EE, UK aflasafe™ Demonstration Scale Plant SOP’s for: 1. Raw material intake/ Sorghum grading. 2. Production - Spore production. 3. Production - Substrate production. 4. Quality control. 5. Maintenance. 6. Cleaning. 7. Water treatment and analysis Registration in Nigeria
  • 17. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Summary of toxicological studies Study Type AF36 aflaguard aflasafe™ aflasafe KE01 aflasafe SN01 aflasafe BF01 aflasafe GH01 and GH02 aflasafe TZ01 and TZ02 aflasafe ZM01 and ZM02 aflasafe MWMZ01 and MZ02 Acute oral Study, no adverse Study, no adverse Waived Study, no adverse Waived Waived Waived Waived Waived Waived Acute dermal Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Acute eye Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Acute Inhalation Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Pulmonary Study, no adverse Study, no adverse Waived Waived Waived Waived Waived Waived Waived Waived Injection Waived Study, no adverse Waived Study, no adverse Waived Waived Waived Waived Waived Waived Hypersensitivity Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Immunotoxicity Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Tier 2 and 3 Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived
  • 18. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Summary of eco-toxicological studies Study Type AF36 aflaguard aflasafe™ aflasafe KE01 aflasafe SN01 aflasafe BF01 aflasafe GH01 and GH02 aflasafe TZ01 and TZ02 aflasafe ZM01 and ZM02 aflasafe MWMZ01 and MZ02 Avian Injection Study, no adverse Study, no adverse Waived Study, no adverse Waived Waived Waived Waived Waived Waived Wild mammal Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived Beneficial Insect Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived Honeybee Study, no adverse Study, no adverse Waived Study, no adverse Waived Waived Waived Waived Waived Waived Avian oral Waived Study, no adverse Study, no adverse Study, no adverse Waived Waived Waived Waived Waived Waived Fresh fish & invertebrates Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Algae Waived Waived Waived Study, no adverse Waived Waived Waived Waived Waived Waived Non target plants Waived Waived Waived Waived Waived Waived Waived Waived Waived Waived
  • 19. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflasafe manufacturing From the laboratory to the industrial process
  • 20. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Soak in water 2 hr Autoclave 45 min @ 121 ° C Soak 5 min in spore suspension Incubate 18hr @ 31°C Oven drying 4 days @ 50 ° C Packaging Clean white sorghum QC 1 2 3 4 5 6 7 300 kg/week Aflasafe production at Food & Nutrition Sciences Lab IITA Laboratory production
  • 21. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Industrial production Aflasafe factory and laboratory in Ibadan Kaolack, Senegal Started producing in June 2019 Katumani, Kenya Operational since Dec 2017 KALRO-Katumani BAMTAARE Factories for Tanzania, Rwanda, and Mozambique being constructed or planned as of now
  • 22. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Production of inoculum Requirements: • Highly-qualified staff • Special laboratory • Rigorous quality control procedures • Tight schedule
  • 23. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Dry inoculum • Shelf life: 3 months* • Reduced contamination risks • Elimination of one laboratory • Uniformity of product quality across countries New process – needs to be refined, optimized, and industrialized
  • 24. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Research – Development – Commercialization (Delivery) Develop baseline data on aflatoxin prevalence Find native candidate atoxigenic strains Field efficacy trials / enhance local research capacity Gain regulatory approval / enhance capacity of local regulator Conduct market analysis, elaborate commercializatio n options Mobilization of private sector, selection of manufacturer and/or distributer partners, awareness raising Test the market with investor, conduct large- scale demonstration and awareness raising Work with investors to manufacture, distribute and build awareness, improve the product Research for Development Partnership for Delivery (Commercialization) 1 2 3 4 5 6 7 8 Pathway for Scale-Up
  • 25. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Demonstrations on-site Test the market, conduct large-scale demonstration and awareness raising`
  • 26. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org SDGs
  • 27. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflasafe: a highly effective technology, but….
  • 28. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Bridging knowledge gaps for improved understanding of aflatoxin biocontrol to guide enhanced performance of biocontrol products • What is the influence of intercropping on efficacy? • Does pesticide use have influence on product performance? • Does application of Aflasafe have influence on soil biological processes and other toxigenic fungi? • Does Aflasafe application influence occurrence of mycotoxins other than aflatoxin? • When is the appropriate time for application of Aflasafe? What is the optimum dose for field application? • What is the optimum rate of application if some inoculum is carried over to the next season after application? • What impact will climate change have on product performance? • What are the advantages offered by selection of widely-distributed strains for constituting biocontrol products over strains with high local occurrence? • Does a multi-strain product offer significant benefit over single strain product?
  • 29. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Bridging knowledge gaps for improved understanding of aflatoxin biocontrol to guide enhanced performance of biocontrol products • Would a two-strain product be effective? • What are the benefits, if any, of area-wide treatment with biocontrol agents? • What approaches should be explored to improve product performance under extended drought? • How can loss of inoculum in the field be reduced from granivores? • What alternate carriers (the current carrier is heat-killed sorghum grain) can be used to reduce cost and increase effectiveness? • What changes in Aflasafe manufacturing processes are possible to improve manufacturing efficiency at different scales? • What are the incremental benefits of integrating various aflatoxin management practices with Aflasafe?
  • 30. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Joint Effort
  • 31. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Questions?
  • 32. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Mali, 10 December 2017
  • 33. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org A. flavus L morphotype
  • 34. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Aflatoxin production ability
  • 35. IITA is a member of the CGIAR System Organization. www.iita.org | www.cgiar.org Communities’ composition