Freyherr production is located in Slovenia, Germany and Republic of Macedonia. Macedonia legalized medical cannabis propagation and end-product formulations in May 2016. We follow highest standards to supply pharmaceutical-grade raw botanical material production, pharmaceutical GMP extraction and GMP liquid, solid and semi solid dosage form production.
Medical cannabis propagation
Extraction of botanical raw material
End product formulations and packaging
We grow our medical cannabis plants in our indoor and outdoor facilities following GAP guidelines.
THC rich varieties
Freyherr cannabis plants with high THC content are cultivated in the Republic of Macedonia, where cannabis production has been regulated by law since 2016. Greenhouse in the size of 2 ha is located in a pristine environment, away from any agricultural areas. our cultivation process follows GAP guidelines, approved by GLOBAL G.A.P. Certification.
Varieties are carefully selected and grown in a way that the product, cannabis flower (cannabis flos), is standardized. The environmental conditions for each growing sector as temperature, humidity, total light and photoperiod are constantly monitored by an automatic system. Standard operating procedures (SOP) are followed in every step of production, including harvesting, drying, storage and onward consignment to ensure consistency of content and to avoid contamination by chemicals as well as fungal and other infestations.
The material is processed in cleanrooms that are part of the facility, designed with respect to the specifics of the handled material. Once the flowers are mature, they are trimmed and dried using GMP compliant machinery. Quality of each flower is carefully checked by educated personnel and supported by analytical tests in accordance with European pharmacopoeia, such as: cannabinoid content, loss on drying, foreign matter, presence of pesticides and microbiological contamination. compliance to quality standards and regulations is inspected by regulatory agencies.
In 2018, we are growing more than 60.000 plants in the soil.
Varieties are White widow (15 % THC), Critical+ (20 % THC) and Dolcecanna (5 % THC, 10 % CBD), provided from CBD botanics.
Freyherr utilizes the cannabis plant material solely for the development of herbal medicinal products. Our primary goals are to extract, separate and purify phytocannabinoids and other pharmacologically-active components from the herbal drug. The extracts are formulated into appropriate dosage forms or sold as bulk to different industries.
We follow detailed SOPs to comply with GMP guidelines. Compliance to quality standards and regulations is monitored by national regulatory agencies.
Freyherr GMP production facility is capable of producing liquid, semi liquid and solid single dosage forms on production scale. Equipped with latest packaging and processing solutions and compliant with latest CGMP standards. All end products are produced under strict SOPs to comply with CGMP guidelines. Compliance to quality standards and regulations is monitored by national regulatory agencies.
We are offering production of products in a different pharmaceutical dosage forms like:
- Bottles with pipettes
CBD rich varieties
Freyherr cannabis plants with high CBD and low THC content are cultivated in the EU countries, mostly Germany, Slovenia and Croatia.
Guidelines of good agricultural practise (GAP), including in-house standard operating procedures (SOPs), are strictly followed throughout every step, from field selection to harvest. All agricultural areas are carefully selected.
Each crop is processed by qualified personnel and machinery. history of each batch is recorded in detail, including environmental conditions and agricultural measures. the quality of the material is checked through analytical support according to European pharmacopoeia.
Seeds of Cannabis sativa L. (hemp) from eu database of registered plant varieties are sown in the soil for cultivation of biomass, intended for extraction. For the production of a cannabis flower of boutique quality, intended for inhalation, own cultivation procedures have been developed by our team. they include planting of clones and individual treatment of every plant. development is accompanied with own academic research.
Worldwide cultivation and breeding have resulted in admixture between species, leading to various chemotypes regarding cannabinoid profiles. As a source of food and fiber products, hemp is being regarded as for the industrial use, though nowadays its popularity is increasing for its CBD with low THC content, which complies with restrictions. Marijuana is recognized as a rich source of cannabinoids and therefore considered as the ‘medical cannabis’, though it can be a very poor source of CBD. Nowadays it is clear that all cannabis types are an appropriate cannabinoid source for medical use, but the cultivars with high cannabinoid content are the most useful for production of pharmaceutical extracts.
An extract is a preparation containing the active ingredient of a substance in concentrated form, made by extracting a part of a raw material, often by using a solvent such as ethanol. Extracts may be sold without removing the solvent as tinctures or can be dried as powders.
A solvent is the liquid, gas or a supercritical fluid in which a solute is dissolved to form a solution.
An active ingredient (AI) is the ingredient in a pharmaceutical drug that is biologically active. The similar term active pharmaceutical ingredient (API) is a central substance of a pharmaceutical product with pharmacological activity.
Supercritical CO2 is used as one of the best extraction solvents for cannabis. It is a special state of carbon dioxide, held at or above its critical temperature and critical pressure, which makes this gas having properties of a fluid. It is non-toxic for health or environment, chemically stable, reliable and non-flammable, making it a desirable candidate working fluid.
Supercritical Fluid Extraction (SFE) is the process of separating one component (the extractant) from another (the matrix) using supercritical fluids as the extracting solvent. Extraction is usually from a solid matrix, but can also be from liquids.
Short path distillation is a distillation technique that involves the distillate travelling a short distance, often only a few centimeters, mostly at reduced pressure. A classic example would be a distillation involving the distillate travelling from one glass bulb to another, without the need for a condenser separating the two chambers.
Winterization of oil is a process of removing the higher melting point parts from oil like waxes or triglycerides by slowly cooling the oil, which enables separation of solidified material from the liquid solvent.
Cannabis is a plant with an outstanding chemical profile. Therapeutically interesting pharmacological ingredients are terpenes and cannabinoids. Cannabinoids can be found in the viscous resin that is produced by glandular structures called trichomes. The most abundant phytocannabinoids are tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC) and cannabinol (CBN).
In the plant itself, they exist in the form of carboxyl acids. In the body, carboxyl acids have different pharmacological effects than their decarboxylated forms, so most cannabis preparations are being decarboxylated before use. Terpenes are volatile substances that give aroma to the cannabis plant and also have biological effects. Terpenes and cannabinoids work in synergy.
Potential for treatment with cannabis is undoubtedly great, but to establish optimal treatments, chemical profile of the preparations needs to be as clear as possible.
Apart from terpenes and cannabinoids, as in every other plant, cellulose, lignin and chlorophylls, proteins, amino acids, hydrocarbons, alkaloids and other nitrogen-containing compounds, enzymes, carbohydrates, flavonoids, fatty acids, phytosterols, carotenoids, vitamins, minerals and other substances are present. They can be partially of fully removed in the process of extraction, depending on the chosen method.
Some procedures for preparing the extracts include use of unhealthy solvents, insufficient extraction or insufficient decarboxylation. Cannabis users are often mislead or not aware what to expect from their product. Cannabis products should be standardised on their cannabinoid contents, which means their potency should be known. Potency testing is especially important in edibles, because the therapeutic effect arises more than half an hour after consumption and can act for hours.
New cannabis strains are constantly being developed. Their increasing offer means increasing diversity of cannabinoid profiles. Moreover, cannabis plants can fluctuate through various stages of plant growth. Even with stable strains, it is very difficult to ensure stable cannabinoid content. Constituent of synthetic medicines are verified in detail. They are certified to be of high quality, effective and safe. And so should be cannabis preparations of natural origin.
In Freyherr, we developed our own HPLC method for analysis of 8 cannabinoids and GC-MS method for analysis of terpenes. We analyse cannabis in every stage of growth and production.
Analysis of cannabinoids and terpenes can employ different chromatographic procedures. In chromatography, the samples are prepared and injected on the column. They separate as they travel through the column with different paces, which depends on their chemical structures. Finally, they are detected and quantified. There are three common, but highly-sophisticated analytical instruments: Gas chromatography–mass spectrometry (GC-MS), High-performance liquid chromatography (HPLC) and Liquid chromatography–mass spectrometry (LC-MS). Those instruments require highly educated and trained personnel.
GC-MS is the most appropriate method for analysis of volatile compounds, such as terpenes, but is not the most suitable for precise detection of cannabinoids. GC-MS does not detect THCA or CBDA directly. Under high temperature exposure, carboxyl groups decarboxylate and a typical GC-MS output is solely a total amount of CBD and CBDA or THC and THCA. This problem can be solved with derivatisation, which is time consuming and includes steps that increase possibility for errors.
On the other hand, HPLC is the method of choice for analysing cannabinoids. Well-developed HPLC method should separate every cannabinoid, which enables analysis of acid components, THCA and CBDA without conversion to THC and CBD. But is not the most appropriate to analyze volatile terpenes.
Every country has its special regulations regarding Cannabis based products. Contact us if you would like us to develop Freyherr products according to your country’s regulation for you to distribute or sell back home.