Linneo Health’s Good Manufacturing Practice (GMP) certification has been renewed, which will allow the company Linneo to continue with the research, cultivation and supply of medicinal cannabis.
Spain-based Linneo Health has had its GMP certification renewed by the Spanish Agency of Medicines and Medical Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS), including its newly built quality control laboratory, which now has the in-house capabilities to analyse its dried flower and cannabis extracts.
CEO, Don Bellamy, commented: “The certification of our new quality control laboratory is a major milestone in our journey to establish Linneo as a leader in the medical cannabis space, providing us with an unrivalled ability to ensure all processes are strictly adhering to global regulatory requirements.
“We believe patients around the world deserve to be treated with cannabis medicine of the highest standard and that is why our product will always be of the highest quality for our partners. The GMP re-certification of our post-harvest facility is further evidence of Linneo’s key differentiator – our commitment to quality.”
Linneo uses its state-of-the-art technology to undertake both microbial and physical-chemical analyses of all cannabis samples, using analytical methods validated to meet European and wider global regulations.
Linneo’s post-harvest facility has also received GMP re-certification until 2024.
Quality and RA director, Maria José Garcia, added: “For our new state-of-the-art quality control laboratory to be validated by a globally recognised regulatory body means we can continue to develop and provide the highest-quality cannabis products.
“Our advanced internal capabilities, which are uncommon for cannabis dry flower manufacturers, further reaffirm our market-leading position.”
Biologists identify “hacks” cannabis uses to make cannabinoids
The research provides insight into how trichomes create high quantities of cannabinoids without the plant poisoning itself.
Previously, it was unknown how cannabis naturally creates high quantities of cannabinoids and terpenes. Now, new research from biologists at the University of British Colombia has defined the “high efficiency” hacks that the plant’s cells use to do this.
A number of biotechnology companies are now using yeast or cell cultures to create synthetic cannabinoids. The process allows for the mass production of cannabinoids to create a high volume of products in order to keep up with consumer demand.
In a new study, published in the journal Current Biology, plant biologists uncovered the microenvironments in which THC is produced and transported in cannabis trichomes, shedding light on several critical points in the pathway of making THC or CBD within the cell.
University of British Columbia botanist who led the research, Dr Sam Livingston, commented” “This really helps us understand how the cells in cannabis trichomes can pump out massive quantities of tetrahydrocannabinol (THC) and terpenes—compounds that are toxic to the plant cells at high quantities – without poisoning itself.
“This new model can inform synthetic biology approaches for cannabinoid production in yeast, which is used routinely in biotechnology.
“Without these ‘tricks’ they’ll never get efficient production.”
Livingston, along with co-author Dr Lacey Samuels, used rapid freezing of cannabis glandular trichomes to immobilise the plant’s cellular structures and the metabolites in situ.
This enabled them to investigate cannabis glandular trichomes using electron microscopes that revealed cell structure at the nano level, showing that the metabolically active cells in cannabis form a “supercell” that acts as a tiny metabolic biofactory.
Until now, synthetic biology approaches have focused on optimising the enzymes responsible for making THC and CBD – like building a factory with the most efficient machinery to make as much product as possible. However, these approaches haven’t developed an efficient way to move intermediate substances from one enzyme to another, or from inside the cell to the outside of the cell where final products can be collected.
This research helps to define the subcellular “shipping routes” that cannabis uses to create an efficient pipeline from raw materials to end products without accumulating toxins or waste products.
Dr Samuels stated: “For more than 40 years, everything that we thought about cannabis cells was inaccurate because it was based on dated electron microscopy.”
“This work defines how cannabis cells make their product. It’s a paradigm shift after many years, producing a new view of cannabinoid production. This work has been challenging, partly the result of legal prohibition and also due to the fact that no protocol for the genetic transformation of cannabis has been published.”
New partnership to commercialise synthetic THCV and rare cannabinoids
Open Book Extracts has partnered with developers of a proprietary chemical synthesis platform that produces ultra-pure, high quality, sustainable cannabinoids, Nalu Bio.
Open Book Extracts (OBX) has entered into a research, development and commercialisation partnership with Nalu Bio.
The partnership will allow Nalu Bio to advance its THCV production method from research and development to commercial-scale manufacturing using its proprietary and scalable synthesis platform.
With a 76,000 sf. NSF- and ISO 9001-certified research and production facility near Durham, North Carolina, OBX and Nalu Bio plan to begin initial production of THCV in September 2022 with market-ready compounds available before the end of the year.
CTO of Nalu Bio, Matthew Roberts, commented: “Our THCV is produced in highly scalable reactors at factory-scale, using low-cost, safe and effective starting materials. Nalu Bio and OBX are both innovators in their respective fields, and this partnership is mutually beneficial for two industry leaders.
“Nalu Bio prides itself on partnering excellence, and we’re excited to deliver high-quality, safe, and low-cost cannabinoid ingredients and products to the market.”
Nalu Bio’s vision for the synthesis and cost-effective mass production of cannabinoids mimics the history of aspirin – the therapeutic value of aspirin for pain relief was discovered, and while initially derived from willow bark, it is now mass produced at factory-scale with higher quality and dosage consistency, which has benefited billions of consumers worldwide as it has become the most commonly used drug in the world.
THCV will be the first cannabinoid available at commercial scale through this partnership, allowing OBX and Nalu Bio to offer the highest quality, most consistent dosage of THCV.
Both OBX and Nalu Bio envision a range of additional cannabinoids to be released through this partnership,including a broad range of cannabinoids from hemp and natural sources, such as CBD, CBN, CBC, CBG, CBT, CBDa, CBGa, CBDV, and THCV.
OBX CEO, Dave Neundorfer, commented: “I am excited about the value Nalu Bio and OBX will bring to the cannabinoid therapeutics market. This partnership is well-positioned to meet the needs of the growing synthetic cannabinoid market and deliver potentially life-changing products to consumers worldwide.”
Greece welcomes first medical cannabis plants from Israel
Mother plants have arrived in Greece, marking the beginning of production for Tikun Europe.
Tikun Europe has welcomed the first mother plants from Israel and will now begin cultivation in the company’s facility at Korinthos, Greece.
Transportation of the plants was carried out by Skyserv Ground Handling Services. The shipment of the plants was made in specially designed containers under controlled environment ensuring the best possible conditions throughout the transportation from Israel to their final destination.
Cultivation will take place in Tikun Europe’s vertically integrated greenhouse unit, with an area of 21,000 m 2 and it anticipates an annual production capacity of 10 tonnes of dry flower.
CEO of Tikun Europe, Nikos Beis, said: “We welcome the first mother plants to our facilities in Greece. Their arrival marks the beginning of production at the factory in Korinthos, which takes us one step closer to the realisation of our commitment.
“Our factory, being the largest pharmaceutical facility in its industry in Europe, is committed to creating innovative, high-quality medical cannabis products.
“A new era is beginning for our country with the operation of our Tikun Europe facility, paving the way for Greece to become one of the main players in the field of production and export of medical cannabis products.”
The plants will be used for propagation under strict protocols that will ensure the preservation of the unique characteristics of the mother plants to the future generations. The facility is expected to reach its full capacity levels gradually in the near future, to deliver a wide variety of finished medical cannabis dosage forms.
The company’s greenhouse and production units are designed to comply with the GACP/EU-GMP standards, and it holds all the necessary licenses and certifications in order for its operation.
COO and vice president of the board of Tikun Europe, Dimitris Giannopoulos, stated: “After completing the construction of our production facility in Korinthos, today signifies another important milestone, that brings us one step closer to the beginning of cultivation of medical cannabis plants in the country.
“The main challenge and opportunity now become the development and production of a complete portfolio of high quality finished medical cannabis products to meet the needs of patients in Greece and in Europe”.
Commercial director of Skyserv Ground Handling Services, Martha Georgila, stated: “We are very happy that Tikun Europe trusted Skyserv to implement the first transport of mother plants in Greece.
“Following all transportation protocols for that type of merchandises, along with the specific storage conditions that were required during their stay at the airport area, we managed to keep them intact until their departure to the company’s factory in Korinthos.”