Medical cannabis cultivation: quality for patients around the world

Medical cannabis cultivation: quality for patients around the world

Explore the world’s largest Colombian company of medical cannabis cultivation and extraction, with the highest quality development of products for patients around the world.

Clever Leaves is a vertically integrated licenced producer of medical cannabis in Colombia. Our medical cannabis cultivation complies with Good Agricultural and Collection Practices (GACP), and our laboratory was built under European Good Manufacturing Practices (EU GMP) standards, with a top of the line extraction facility with a capacity to produce 3,000 litres of EU GMP compliant full spectrum cannabis oil a year.

Clever Leaves began operations in May 2016 and has as its objective to become the world´s largest medical cannabis grower by 2023 with over 10 million ft2 (100 hectares) of growable terrain.

Northern Swan, our strategic partnership, is a New York based investment firm focused on global early and late stage investments in heavily regulated industries, such as the cannabis industry. In 2019, Clever Leaves obtained full sponsorship from Northern Swan, positioning the company as one of the most important players within the development of the cannabis industry in Colombia and the world.

Clever Leaves has already developed and strengthened associations with different clients around the world, portraying itself as one that is not only a medical cannabis cultivation company, but also adding value to the development of the industry.

Our growable terrain and pharmaceutical extraction plant, as well as our passionate team of workers, has as its main objective to develop the highest quality products for patients in Colombia and the world

Clever Leaves covers the entire chain of medicinal cannabis, starting from the harvest of the seed all the way to the patient. The patient’s wellbeing is Clever Leaves focus, and the reason we base our work on their specified needs to discover the most appropriate genetics. Through scientific rigour, we create the most efficient products that will contribute to a better quality of life.

We have an innovative, expert and multidisciplinary team, which not only provides knowledge of various industries such as pharmaceutical, agroindustry and floriculture, mass consumption, organic chemistry, biotechnology and business, but also a great passion for the mystique of medicinal cannabis.

Clever Leaves is the first and only Colombian company that has exported medical cannabis into Canada, to date

This is a milestone in the history of Colombia and the medical cannabis industry, as it illustrates that Colombia is positioned to become a global leader in a highly technical industry by being the first company in Colombia to receive authorisation from both regulation entities in Colombia and Canada.

Health Canada, Canada’s government agency responsible for national public health and oversight of the medical cannabis industry, issued six authorisations to Clever Leaves on January 16 to import dry cannabis flower for scientific purposes. On 29 January 2019, the Colombian National Narcotics Fund (El Fondo Nacional de Estupefacientes or the “FNE”) granted the approvals necessary to export the material from Colombia. Clever Leaves began exportations in mid-February.

“This is a milestone in the history of Colombia and the medical cannabis industry, as it illustrates that Colombia is positioned to become a global leader in a highly technical industry. Foreign investment, job creation and innovation in pharmaceutical technology are just some of the benefits that Clever Leaves generates for the country and the global cannabis and pharmaceutical markets,” reassured Andrés Fajardo, CEO of Clever Leaves.
Clever Leaves met all the requirements of Health Canada to obtain the import permit, which demonstrates the high quality of its medical cannabis cultivation practices, extraction facilities, operating procedures, and management team.

The Colombian government granted Clever Leaves the first crop quotas for exportation and commercialisation

Clever Leaves is the first Colombian company authorised by the Ministry of Justice to harvest medicinal cannabis for commercialisation.

On 21 December 2018, the Ministry of Justice and Law issued resolution 1302 whereby it granted Clever Leaves a quota for the cultivation of medicinal cannabis. This quota consists of 175 mother plants, which can be used for the propagation, for commercial purposes, or for the elaboration of medicinal grade products for patients in Colombia and the world.
According to this authorisation, Clever Leaves could use this quota for mother plants, which are in the vegetative stage and are ready to propagate thousands of plants within the crop quota that Clever Leaves will obtain by 2019.

Obtaining this quota, meant that Clever Leaves had to prove to the government institutions that they have engaged in all the research phases as well as in the stabilisation phases of the cultivation cannabis plants. At the same time, they had to perform scientific trials to obtain extracts and products that will guarantee stability and safety to the patients.

Julián Wilches, Co- Founder and CRO of Clever Leaves, reassured that the company, through its responsible and rigorous work has been leading the industry of cannabis for medical purposes.

“Colombia has a favorable regulatory framework and political environment for the development of the industry and for the generation of added value in the country. Adding a process of industrialisation, research and serious exports, portrays the potential that the country has to become the leading exporter of medicinal cannabis in the world,” says Wilches.

Prior to obtaining the quota of the 175 mother plants, Clever Leaves obtained the filling quotas for research purposes in 2018:

  • Cultivation quota of more than 30 thousand plants for research purposes; and
  • Quote for the manufacture of derivatives for 514 kg of dried cannabis flower for research purposes.

Innovation in processes and technologies for medical cannabis cultivation and laboratory: A crop with the best practices and technologies

Colombia has huge advantages to position itself as one of the largest global export leaders in the world of an industry that is each day gaining more strength. Among these competitive advantages, we can find:

  • Colombia’s geographical location on the Equator line gives us in Boyacá, 12 hours of sunlight, which is crucial for the cultivation of cannabis;
  • Clear regulatory framework that contributes safety to the industry and for the operation of the companies;
  • Advantages in low-cost production. Compared with other models that have been developed in distant countries, the operating cost in Colombia is substantially favorable. In terms of capacity and infrastructure, Clever Leaves also has a great advantage;
  • Colombia is a country of agricultural and agroindustry vocation. The knowledge that we have as a country in the flower sector coupled with the expertise of the Clever Leaves team in medical cannabis, gives us a ‘win-win’ result.

In Clever Leaves, we focus on the quality of the cannabinoids that can be extracted from our plants, which have been analysed by our scientific team to determine those genetics that could aid different pathologies of the patients. We strive to offer our consumers and clients high value-added products derived from cannabis plants, helping patients in Colombia and around the world to achieve enhanced wellbeing.

We focus on how productive our plants are in terms of growth and volume capacity of extraction. The productivity of the plant is measured in the amount of oil that can be extracted from its flower, the component that interests us as an industry are concentrated. Currently, Clever Leaves counts with a bank of more than 170 genetics.

Innovation, technology and social responsibility

In the harvest process, Clever Leaves innovation goes from soil preparation, biological control, cross-cutting management of crop methodologies, sustainable use of water, all the way to the ventilation of the greenhouses. We count with an Israeli irrigation system of high efficiency and at Clever Leaves we manage a GPS system to control any type of disease or plague to which the plants are vulnerable.

Clever Leaves have implemented the latest greenhouse technology and have managed to work with precision agriculture to become one of the world’s most important players in the medicinal cannabis industry. The model has focused on the reuse of resources to control any impact on the environment. Further on, 90% of the water used is being recycled from rainwater, thus contributing to a sustainable operation.

Our future: An agroindustry of quality and scientific rigour

With the goal of operating on over 100 hectares by 2023, Clever Leaves is in the process of a significant expansion and becoming the leading cannabis operator in the world. The growth process will depend to a large extent on the innovation and rigourous research into new medical cannabis cultivation possibilities, strains and new monitoring systems that expand current capabilities and allow us to be the most important player in the industry, with an increasing participation in national and international markets.

Extraction laboratory: a production plant with state-of-the-art technology, innovation and development

Our plant, with 1,300 m2 and projected at 4,000 m2 is being certified in Good Manufacturing Practices (GMP) for its pharmaceutical grade extraction plant. Clever Leaves has one out of the six available CO2 extraction plants of cannabis that exist in the world, being the only one in South America. The dried flower is received in the laboratory where the extraction processes are carried out both by CO2 and by Ethanol. In the plant, the oils are extracted: crude, distilled or by isolated components.

In the laboratory, a team of scientists, doctors, and researchers oversee all the process phases that start from the preparation of the raw material moving into the decarboxylation, extraction, winterisation, distillation, chromatology, and packaging. At the end of this scientific process, the oil is obtained in full spectrum (the highest concentration), distillates (highly refined oils) and isolates, where the cannabinoids extracted from the oil are completely separated.

At Clever Leaves, we work towards potentialising the cannabis plant, through scientific studies, analysis and adjustments to our processes to make them more efficient. All with the objective of producing products with the highest quality standards.

Likewise, we are committed to collecting all the relevant information that allows us to provide feedback on the development of products, and thus continue to offer medicines based on medicinal cannabis with pharmaceutical quality.

The evolution of the industry has driven us for the need of an effective team that can define solutions and discover adjustments and improvements that will strengthen the processes of production. Therefore, Clever Leaves multidisciplinary team works in an articulated manner to determine new processes, strains, crop management, and possible products.

At Clever Leaves we want to become the leaders in the process to develop a unique model of patient care which, with an innovative perspective, will differentiate us in the market and help build, with the support of our scientific team, protocols for the diagnosis and management of different pathologies that can potentially be treated with medicinal cannabis, which until today continue to be developed.

Genetics: Research applied to medicinal cannabis

Plant biotechnology is the set of techniques or processes that are used in the study of the plants to potentialise their use.

The medicinal cannabis industry is a clear example of plant biotechnology, since cannabis plants are used as a source of medicine after having undergone a process of transformation or modification.

For Clever Leaves, there is a constant need to think about better processes that allow us to reach increasingly challenging production scales. From the innovation perspective, we work on developing genetics that meet medical needs and that are each time more resistant and productive in their culture environment, always keeping in mind the welfare of patients.

Currently, Clever Leaves works with more than 170 genetics of the cannabis plant. All the varieties of cannabis that exist in our seed bank have been obtained within national territory and were legalised by means of the seed source created by the ICA (which allowed the reporting of cannabis varieties until 31 December 2018).

The cannabis strains that are used for the medicinal cannabis industry are differentiated by the form of cultivation and its respective treatment. For medicinal or therapeutic purposes, the cultivation of genetics under controlled conditions, while following high quality and control standards, is very important to ensure that the final product will be of high quality, efficient and safe for patients. In Clever Leaves, this is represented in good biological control practices by not using pesticides and controlling the amount of heavy metals.

Medical Unit: The science applied to medical cannabis with an ultimate goal: the wellbeing of the patients

Clever Leaves is committed to advance in the sector of science and research as well as strengthening the development of products that will contribute to the wellbeing of the patients in Colombia and the world. That’s why we investigate and develop our own genetics which have more than 170 varieties of cannabis that can offer better alternatives for the patients.

Clever Leaves has already established academic alliances with different hospitals and with the Colombian Society of Anesthesiology for the development of research and educational projects that will strengthen the knowledge about the industry. At the same time, it has developed webinars, management guides with a scope of research and 2 diploma’s of medicinal cannabis with the Universidad del Rosario.

Likewise, with the interest focused on the patient, Clever Leaves is developing research
protocols aimed at finding quality solutions for sensitive pathologies.

Clever Leaves medical and scientific team, in addition to supporting the development of products and the strengthening of medical cannabis education, is working on different patient care projects.

Scientific evidence supports the use of medicinal cannabis for chronic pain, spasticity due to multiple sclerosis, and nausea and vomiting due to chemotherapy. There are other pathologies susceptible to benefit from the use of medical cannabis, however, they are still yet to be corroborated with scientific evidence.

In terms of products, we are in the process of developing a portfolio for three specific segments:

  • The B2B line that corresponds to the sale of raw materials that result from the extraction processes (crude oil, distilled and isolated) and that are later transformed by other laboratories into final products within a wide spectrum of possibilities in the health and beauty markets.
  • The line of pharmaceutical grade final products, which correspond to the development and elaboration of pharmaceutical grade medicines, authorised by regulatory bodies of each country to which the product arrives, with high innovation components that are supported by a rigorous process of checking the effectiveness of the drug in the treatment of a certain pathology, and with the application of added value elements in the product (packaging and highly effective vehicles) that suits the particular needs of each patient.
  • The line of wellness products for health, which corresponds to the development of products in the field of health and beauty, and that its development is based mainly on the potential of the non-psychoactive plant component, known as CBD, to offer people alternative product solutions that complement their day to day resulting in a better well-being and their health conditions in general.

3 stories, one startup, one objective: Clever Leaves is in the TOP 5 in the world in terms of medicinal cannabis

One could say that 2010 was the year that opened the path of a dream that years later would create one of the most important medicinal cannabis companies in the world.
At that time, Andrés Fajardo and Gustavo Escobar worked in IQ Outsourcing, a Colombian Company of the Sanford Group, which creates and implements integral solutions for the efficient, intelligent and safe management of critical processes of large companies that belong to the financial, health and telecommunications sectors.

Andrés, as CEO, led the business and operational transformation of the company (more than 2,200 employees and revenues of USD $40 million (~€35.7m)), through a dynamic process of growth and internationalisation. Escobar, as vice president, focused his responsibilities on strategic international expansion, through the exploration of the BPO industry in several countries of Latin America and the United States. He also led the M&A processes and the development of new business with international industries, specifically within the health sectors.

The partnership they developed, and the values that they shared, within their business and social lives, quickly led them to found Mojo Ventures, a startup focused on generating growth with unprecedented profitability. Working together through this concept which others admire, Mojo Ventures executed under a business philosophy structured in two edges; first, working with an inspired team that has the ability of achieving extraordinary results regardless of the specific tasks that they must perform. On the other hand, believing that the combination of strategy, execution, and resilience will contribute to their business objectives.

In 2000, Escobar had the opportunity to live in the Netherlands, a country that decades ago developed a strong culture around the acceptance of the cannabis plant. This revelation allowed him to understand and grasp the impact of the potential of this industry and helped identify the opportunity of growth of this sector in Colombia. Thanks to the strong regulation in Colombia that kept advancing in 2015, and realising the impact and the benefits that this plant has on the wellbeing for the patients, Escobar realised on the importance of joining this business.

In 2015, thanks to Escobar’s passion, Wilches, a skydiving professional, became part of this team of entrepreneurs. As Director of Policy against Drugs of the Ministry of Justice and Law and adviser to the Presidential Program against illicit crops, promoted an integrated vision based on evidence and public health, managing to point out the future agenda regarding this issue in Colombia and the world. On the other hand, Wilches was also the Sub Director of Inter Institutional Articulation in the Office of the Attorney General of the Nation.

At that time, Wilches was studying in the Congress of the Republic the bill that would regulate the medicinal cannabis in Colombia. While studying, Wilches was able to grasp and understand the potential of this industry to unite entrepreneurship with the knowledge of regulation and corporate expertise.

Fajardo, Escobar and Wilches sat together to figure out a way in which they could give back to the country, not only economically, but also socially. Further on, they brainstormed on work teams made up of members that would be capable of accomplishing projects without losing the central focus of having the people as their most important asset of the company. Through this meeting, Clever Leaves was born in 2016, with the goal of impacting the lives of many through medicinal cannabis and changing the image of Colombia in the world.

Julián Wilches
Co-Founder & Corporate and Regulatory Affairs Director
Clever Leaves
+1 305 927 6642
julian.wilches@cleverleaves.com
https://www.cleverleaves.com/about-us/

Please note, this article will appear in issue 10 of Health Europa Quarterly, which will be available to read in July 2019.

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