The Future of RNA Pesticides
When discussing the development of pesticides in general, we typically separate the discussions of the active ingredient and the drug delivery system (DDS). In chemical pesticide development, discovering an effective active ingredient is extremely challenging and consumes significant time and effort. Conversely, once the active ingredient is identified, discussions about the DDS progress relatively smoothly.
In the case of RNA pesticides, the approach differs from that of chemical pesticides. The RNA sequences, which are the active ingredients, can be relatively easily discovered from genomic information. However, discussions around the DDS are more complex. We must consider methods that enhance sustainability while enabling efficient mass production.
We envision a future where information on RNA interference becomes open source, and companies fiercely compete in the realm of DDS. This is because, while the information on RNA interference remains scientifically constant, DDS represents an area where each company’s technological advantages and patents are less likely to be overturned.
MOVE aims to build an RNA pesticide delivery system that pioneers such a future. To function as a robust RNA pesticide platform, we are simultaneously developing software that connects information on various crops and RNA pesticides, which have not yet been integrated.
Schedule
Pesticides Examination
Our product is a pesticide and must comply with standard pesticide examination procedures, which include the following tests:
Acute Toxicity Tests
- Acute oral toxicity (rats, mice)
- Acute dermal toxicity (rats, rabbits)
- Acute inhalation toxicity (rats)
- Skin irritation and eye irritation (rabbits, guinea pigs)
- Skin sensitization (guinea pigs)
- Acute neurotoxicity (rats)
- (Acute delayed neurotoxicity: chickens)
Medium to Long-Term Toxicity Tests
- Subacute oral toxicity (90 days: rats, mice, dogs)
- 21-day dermal toxicity (rats)
- (Subacute inhalation toxicity (90 days: rats))
- (Subacute neurotoxicity (90 days: rats))
- (28-day delayed neurotoxicity: chickens)
- Chronic toxicity (1 year: rats, mice, dogs)
- Carcinogenicity (1.5–2 years: rats, mice)
- Reproductive toxicity (rats)
- Developmental toxicity (teratogenicity: rats, rabbits)
- Genetic toxicity (mutagenicity)
- Others
General Pharmacological Tests
- Effects on physiological functions
Metabolism Tests
- Animal pharmacokinetics
- Plant pharmacokinetics
Environmental Impact
- Soil fate tests
- Water fate tests
Residue Tests
- Residuality in crops and subsequent crops
- Soil residuality
After conducting these tests in collaboration with testing companies, we calculate the No Observed Adverse Effect Level (NOAEL), which is the maximum dose that does not produce harmful effects in test animals; the Safety Factor, a value used to estimate human impact from animal NOAEL; the Acceptable Daily Intake (ADI), which is the NOAEL divided by the Safety Factor, indicating the daily intake amount that is not hazardous to humans; and the Maximum Residue Limit (MRL), which is the maximum concentration of pesticide residue adjusted so that human intake does not exceed the ADI. Regulatory authorities use these test results to determine whether the pesticide is safe. These tests cost approximately $10 million and take about 10 years to complete before the pesticide can be registered.
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Confirmation of Efficacy in Laboratory Conditions
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Efficacy Tests
- Evaluation of RNA interference effects against pests and pathogens in laboratory settings.
- Measurement of RNA stability and duration of effect.
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Efficacy Tests
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Establishment of Mass Production Methods
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Scaling Up Production Processes
- Transition from lab scale to pilot scale.
- Design and optimization of bioreactors.
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Optimization of Production Conditions
- Optimization of culture media and conditions for MV production.
- Improvement of production efficiency and yield.
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Scaling Up Production Processes
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Safety Testing and Pesticide Registration Application
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Conducting Safety Tests
- Implementation of the aforementioned tests.
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Submission of Pesticide Registration Application
- Preparation of application documents based on each country’s pesticide registration system.
- Responding to the review process and providing additional information.
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Conducting Safety Tests
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Commencement of Sales
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Marketing and Promotion
- Identification and segmentation of target markets.
- Deployment of brand strategies and promotional activities.
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Building Sales Channels
- Conclusion of contracts with sales agents and distributors.
- Utilization of online sales platforms.
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Start of Production
- Establishment of MOVE production facilities.
- Commencement of production.
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Marketing and Promotion
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Market Expansion
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Development of New Products
- Development of RNA sequences targeting new pests and pathogens.
- Consideration of integrated products with other agricultural materials.
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Entry into International Markets
- Researching overseas regulatory requirements and obtaining approvals.
- Building an international sales network.
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Development of New Products
Risks and Countermeasures
In the MOVE project, various risks are anticipated in the practical application of RNA pesticides. First, there are safety concerns regarding impacts on non-target organisms. To address this, we will conduct detailed impact assessments and ecosystem monitoring, establishing safe usage guidelines.
As a regulatory risk, obtaining approval may become challenging due to differences in laws and regulations across countries and regions. We will mitigate this by collaborating with regulatory authorities from an early stage and preparing the necessary data.
Technical risks include challenges during large-scale production. We will overcome these by optimizing production processes, training specialists, and collaborating with industry partners.
Economic risks involve the possibility of increased production costs burdening farmers. We will ensure economic feasibility by improving production efficiency, implementing cost-reduction measures, and utilizing subsidies.
Acceptance risks stem from skepticism among farmers and consumers toward new technologies. We will deepen understanding and build trust through education and demonstrations.
Other risks include intellectual property issues, biosecurity, development of resistance, and long-term environmental impacts. For each risk, we will take appropriate measures based on expert advice to enhance the success and sustainability of the project.