Start-up company: success story from Lithuania processing industrial hemp

Transcription

1 Start-up company: success story from Lithuania processing industrial hemp Rimantas Venskutonis Professor of Department of Food Science and Technology, Kaunas University of Technology Appointed Lead Research Fellow, Polli Horticultural Research Centre, Institute of Agricultural and Environmental Sciences, Estonian University of Life Sciences

2 Presentation outline Introduction: Hemp - an old new crop: nutritional and legal issues, globally Short history of Endobiotech New projects, Future developments Conclusion

3 Hemp: a new/old crop When Bayer introduced aspirin in 1899, Cannabis was America s number one painkiller. Until Cannabis prohibition began in 1937, the US Pharmacopoeia listed Cannabis as the primary medicine for over 100 diseases.

4 History of hemp Sean Murphy m/hemp-new-miracle-crop/ Hemp is the most useful plant in the world if not the universe. Popular Science came out with an article in 1938 calling hemp the new Trillion Dollar Crop

5 Modern uses for the hemp plant

6 The same species (Cannabis sativa L. ) - different composition and applications Industrial hemp vs Medicinal cannabis vs Marijauna (Recreational cannabis) Cannabis sativa vs Cannabis sativa vs Cannabis sativa Non-psychotropic effects vs Psychotropic effects PHYTOCANNABINOIDS CBD and many other structures THC (mainly)

7 Industrial hemp vs marijuana Low resin hemp: Can grow up to 5 m tall High resin hemp: looks a lot more like marijuana flowers than true industrial hemp

8 The main legal issue Tetrahydrocannabinol Cannabidiol Medical marijuana can have up to 20% THC and no CBD, where hemp has less than % THC and high levels of CBD

9 Legal issues: medicinal and recreational purposes (includes high THC)

10 EU: only medicinal and industrial Medical Cannabis applications Regulations For CBD Products In Europe

11 European hemp cultivation (ha)

12 Medicine: Active pharmaceutical ingredient (API) CBD: only drug or also food ingredient? Pharmacological actions of nonpsychotropic canabinnoids

13 Authorized cannabis-based medicines in Europe Brand name Form Indications Description Sativex (Nabiximols) Extract of cannabis (oil): THC and CBD MS (multiple sclerosis Sublingual spray Marinol (Dronabinol) Synthetic delta-9-thc Cancer treatment, AIDS, MS Gelatin capsule Cesamet (Nabilone) Synthetic cannabinoid similar to THC Cancer treatment Capsule Bedrocan Dried flower tips (sometimes powdered); five strains available Various Plant material

14 How innovative business starts: Somebody has to raise the idea and give seeding support : The owner of Danish company Endoca visited Department of Food Science and Technology Small project was started on CO2 extraction of industrial hemp leaves. Extraction parameters were optimized for extract yield and (preliminary) phytocannabinoids : Start-Up Plantex Biotech founded in the premises of Technopolis (KTU): 3 staff members

15 Activities: R&D and others Development of processing technologies Development of products Establishment of GMP, ISO Global logistics Preparation of applications for funding Legal issues

16 Development of processing technologies Selecting low THC cultivars Growing and harvesting of hemp Postharvest handling: Drying of harvested hemp Extraction by SFE-CO2 Dehydration of crude extracts Winterization to remove partially waxes Decarboxylation Fractional distillation Crystallization Chromatographic purification (removal of THC)

17 Development of products Crude extracts (purchase of service from the SFE plant in Poland) Food supplements with different concentration of CBD, CBDA (3, 5, 10, 15, 30 %) Chewing gum Pure (>99%) CBD crystals (GMP Pharma) Cosmetic products Oil from seeds

18 Products (marketed by Endoca)

19 Products CBD Suppositories Total:500mg CBD

20 Products: skin care

21 GMP, ISO certification for food handling operators

22 GMP certification for API producers

23 Preparation of applications for funding 1. Safer foods 2. Functional foods 3. Biorefining Expected products and technologies Smart Specialization priorities LT

24 Preparation of applications for funding Lithuanian Business Support Agency (LBSA) Agency for Science, Innovation and Technology Research Council of Lithuania Central Project Management Agency

25 Preparation of applications for funding Smartinvest (foreign investments) Intelekt (national investments) Support (depending on enterprise size): up to 45 % for infrastructure; up to 70 % for R&D Establishment of R&D infrastructure for innovative biorefining technologies of botanical materials, development and commercialization of functional ingredients thereof Total budget: 3,659,998 Eur; Support from LVPA: 1,717,274 Eur

26 Evaluation of composition and properties Further fractionation/purification Development of functional ingredients Application possibilities Smartinvest project: R&D Selected plant materials (botanicals) Supercritical CO 2 extraction Residue Lipophilic fractions Conventional, MA, UA extraction Residue Hydrophilic fractions Enzyme assisted extraction Residue Other soluble fractions

27 Smartinvest project: infrastructure Supercritical fluid extraction unit (2x150 L extractors 1 MEur) Conventional extraction unit Ultrasound/microwave extraction unit Bioreactor unit Molecular (fractional) distillation unit ( 0,5 MEur) Chromatographic separation unit Product development unit (nano/microencapsulation)

28 Other LT companies: Satimed products

29 The main legal issues for industrial hemp (foods and food supplements) Seeds ant their products: legal (no question to allow or not to allow ) Contains traces of THC The problem : How much of THC may be tolerated? Leaves for non-medicinal products with nonpsycotropic phytocannabinoids: - to allow or not to allow - if allow, how much

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31 The largest hemp grower, processor, and trader in the Baltic countries and the largest organic hemp grower in Europe EU ORGANIC HULLED HEMP SEEDS EU ORGANIC HULLED HEMP SEEDS EU ORGANIC HEMP SEED OIL EU ORGANIC HEMP PROTEIN EU ORGANIC HEMP FLOUR

32 Internet business of CBD products

33 Should non-psychotropic cannabinoids be food/food supplement ingredients? Will phytocannabinoids appear in the list of EU documents?

34 Three distinctions by dose are proposed by the EIHA At high doses, CBD can be a medicinal product, regulated as such (more than 200 mg oral/day). At physiological doses CBD should be regarded as an OTC-product (over the counter) or a food supplement ( mg oral /day) equal to substances, such as valerian, Ginkgo Biloba, some vitamins and iron products. Low CBD concentrations and doses should be allowed in food products without any restrictions (20 mg/day). Additional aspects such as route of administration, indication area, maximum single / daily dose and pack size can be used to further fine-tune the regulation. Famous warning letters, which were sent to numerous CBD hemp oil vendors by the FDA in 2015 and The letters told the vendors that they needed to stop making medical claims about CBD hemp oil.

35 The debate today (USA) Farmers and politicians are trying to convince the government as well as the DEA to separate the two plants and allow the cultivation and production of hemp for economic and natural resource benefits DEA: drug enforcement administration

36 U.S. cannabis retail sales estimates, $ 10 9 Vending machines selling industrial hemp products could be coming to a Kentucky city bardstown-company-to-sell-industrialhemp-products-through-vendingmachines-in-select-ky-cities/

37 Summary of biorefining of hemp threshing (cleaning seeds) residues 1st STEP: SFE-CO % CBD = 2.5 %; CBDA = 26.1 % 2nd STEP: PLE-Ac 2 4.3% Phenolics = 14.8 % (5.5 mg/g) 3rd STEP: PLE-EtOH/H 2 O % Phenolics = 12.5 % (26.9 mg/g) 4th STEP: EAE % TOTAL 52.4 % Residue % 5 products; THC conc.? PUFA OIL PROTEINS

38 D: Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) BgVV calculations for THC guidance values in foodstuffs

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40 Comparison of LOEL and uncertainty factor of THC in hemp food goods based on BgVV 1998, EFSA 2011 and 2015, and nova-institute proposed (2015)

41 THC guidance values and limits in food goods in selected countries worldwide Note: as for 2015 nova-institute data

42 Final nova-institute/eiha proposal for THC regulation in intermediate and final food goods per category, and equivalent values for listed countries (in mg/kg)

43 Conclusion It is just a plant, just a very useful plant Existed and has been used for millennia Very useful and deserves 21 st century research Hemp is not intoxicating Growers can be reasonably regulated until a system can be established All processes could be located on site reducing need for transportation The judges are not toxicologists