Sweet, Sweet Success
The Centro de Tecnologia Canvieira (CTC), a sugarcane consortium in Piracicaba, Brazil, knew it had a potential blockbuster biotech event on its hands but needed help to revamp its regulatory science capabilities and make submissions across the world.
Background
Centro de Tecnologia Canavieira (CTC) is a global leader in sugarcane research and development, renowned for its cutting-edge innovations in sugarcane breeding, biotechnology, and agricultural practices. As a key player in advancing the sugar industry, CTC has consistently sought to unlock the crop’s potential for sustainable and profitable agriculture.
Hjelle Consulting Group (HCG) is a premier consulting firm specializing in regulatory strategy, policy navigation, and compliance for agricultural biotechnology and innovative crop solutions. With a track record of enabling clients to achieve seamless regulatory approvals across international markets, HCG is known for its deep expertise, strategic foresight, and collaborative approach.
The relationship between CTC and HCG (previously Hjelle Advisors) began in 2016 to address the growing complexity of global regulatory environments for agricultural biotechnology, particularly as CTC sought to secure approvals for its genetically modified sugar varieties. These innovative sugar varieties promised increased yield, enhanced resistance to pests (such as the sugarcane borer) and diseases, as well as reduced environmental impact – making this a transformative solution.
Achieving the Goal of Product Commercialization
HCG played a pivotal role in accelerating CTC’s path to commercialization for its innovative sugarcane varieties and systems. With deep industry expertise and a hands-on approach, HCG provided CTC with unparalleled access to regulatory and scientific experts like Dr. Ron Lirette and Dr. Stephen Waters, both with decades of experience in agricultural biotechnology and regulatory affairs. In fact, Ron spent roughly three months at CTC’s headquarters in Piracicaba, Brazil helping the team to modernize facilities and create scientific support for CTC’s global regulatory strategies.
The collaboration helped to refine data generation practices, scientific methodology, quality assurance, material tracking, and process controls for sugarcane testing. He provided very important advice on pipeline product design in step with global regulatory requirements. Working alongside CTC’s Regulatory team, this work expedited regulatory submissions and approvals and also helped control costs by streamlining workflows and reducing inefficiencies. Additionally, Ron focused on training both scientists and regulatory affairs professionals to with the skills necessary to maintain high standards independently. CTC’s Regulatory function today is world class—and CTC’s overall leadership in global renewable energy through the Brazilian Sucro-Energy Sector benefits the entire world.
By identifying potential regulatory hurdles early and crafting a precise, science-backed strategy, HCG positioned CTC for success, enabling them to move through complex approval channels and bring their groundbreaking sugarcane innovations to market. Beyond regulatory navigation, HCG served as a powerful advocate for CTC in the broader scientific and policy landscape. Leveraging long-standing relationships with key regulatory agencies, the team worked to focus data requirements appropriate for this sector, often cutting through red tape and eliminating unnecessary delays. Their proactive engagement with policymakers and regulators not only expedited approvals but also helped shape a regulatory environment that supports innovation in sustainable agriculture.
The Uniqueness of Sugarcane
Sugarcane holds a critical position in the global agricultural economy, especially relating to renewable energy in the form of ethanol for transportation. As one of the most cultivated crops worldwide, sugarcane is a primary source of sugar, ethanol, and byproducts used in various industries, including food, energy, and bio-based materials. The crop’s economic significance is especially pronounced in tropical and subtropical regions, where it provides livelihoods for millions of farmers and workers. In terms of production, Brazil is the leader with 25% of global production, totaling 45.54 million metric tons in the 2023-2024 period.
But in Brazil, the so-called “Sucro-energy Sector” effectively only has two products: the highly purified sucrose and food grade ethanol and ethanol for use in flex automobiles with engines that can run on up to 90 % ethanol fuel. Therefore, advances made by CTC on sugarcane also play a pivotal role in renewable fuel, climate change and energy security. Furthermore, sugarcane’s ability to sequester carbon and its potential for ratooning (multiple harvests from a single planting) enhance its sustainability profile.
The Economic Impact of the Sugarcane Borer
One of the most significant threats to sugarcane yield and revenue generated from sugar production and other byproducts is the sugarcane borer. The larvae bore into sugarcane stalks, resulting in reduced stalk weight, diminished juice quality, and decreased sugar recovery. CTC’s sugar varieties show strong resistance to the sugarcane borer which is achieved through the expression of the Cry1Ab protein, derived from Bacillus thuringiensis (Bt).
A study conducted by Pecege Consultoria e Projetos, in partnership with CTC, highlighted the impact of the sugarcane borer on industrial processing costs. Sugarcane with an 8.5% borer infestation resulted in an 18% higher ethanol processing cost compared to uninfested cane (R$285 vs. R$235 per ton). Similarly, white sugar processing costs increased by 6% under the same infestation level (R$231 vs. R$218 per ton).
The Role of Hjelle Consulting Group
Hjelle Consulting Group’s involvement was instrumental in CTC’s journey toward global regulatory approval for its genetically modified sugar varieties. Key contributions included:
1. Strategic Regulatory Planning: HCG worked closely with CTC to develop a tailored regulatory strategy that accounted for the specific requirements of target markets. This included conducting regulatory landscape analyses, identifying key stakeholders, and prioritizing countries with significant market potential.
2. Scientific Dossier Development: HCG played a critical role in preparing high-quality scientific dossiers that addressed the unique aspects of genetically modified sugarcane. This involved integrating data on molecular characterization, environmental risk assessments, and food/feed safety studies to meet diverse regulatory standards. Significant training, data assessments and strategy discussions broadened CTC’s Regulatory Science and Affairs—now the premier group in sugarcane globally.
3. Stakeholder Engagement: Recognizing the importance of transparency and collaboration, HCG facilitated engagements with regulatory authorities, scientific committees, and industry groups. These efforts helped build trust, clarify technical aspects, and address concerns related to genetically modified sugarcane.
4. Navigating Challenges: HCG’s deep understanding of regulatory nuances enabled proactive management of potential hurdles. From addressing biosafety concerns to aligning with country-specific policies on genetically modified organisms, HCG provided critical guidance at every stage.
5. Future Foresight and Advising: As regulatory goals are met, there still is the task of continuing product development and approvals to optimize performance against disease, pests and weeds. In addition, policy and trade changes can influence, both positively or negatively the overall regulatory environment; HCGs deep knowledge and understanding of these areas provided valuable insight for future product success.
Outcomes and Impact
The collaboration between CTC and HCG resulted in significant milestones, including:
- Regulatory approvals in multiple key markets including the U.S., Canada, and Brazil, paving the way for the commercial release of CTC’s genetically modified sugar varieties. Gained approval in China for importation and in Japan, helped underscore the importance of policies for highly purified products like sugar and ethanol.
- Modernization of facilities in Piracicaba (Brazil) and helped facilitate of advanced technology and research collaborations at the Danforth Plant Science Center in St. Louis (U.S.) to help develop products using genetic modification and genomic editing.
- Enhanced Policy understanding of the incredible Brazilian Renewable Sucro-energy Sector helping CTC in its’ goals to bring cutting edge advantages of biotechnology to sugarcane growers.
- Increased global recognition of sugarcane’s potential as a sustainable and innovative crop solution.
Beyond regulatory achievements, the partnership demonstrated the value of combining scientific innovation with strategic regulatory expertise. By navigating the complexities of global regulatory frameworks, CTC and HCG have set a precedent for successful collaboration in advancing agricultural biotechnology in the Brazilian Sucro-energy sector.
Conclusion
The case of CTC and HCG underscores the transformative potential of strategic partnerships in the agricultural sector. As the global demand for renewable energy and sustainable and innovative crop solutions continues to grow, their collaboration serves as a model for achieving regulatory success and driving meaningful impact in the agricultural biotechnology landscape. The CTC Regulatory team are now the global leaders in this space.
HCG’s ability to create synergy by understanding regulatory environments, global agriculture trade, business and product development, as well as their decades of scientific experience and knowledge make them an asset for any agricultural technology firm seeking global regulatory approval.
