Trichome Pharma has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to cultivate medicinal cannabis for research purposes.
Trichome Pharma has been building its research and development platform over the last 18 months. The company’s aim in building the facility is to increase access to medicinal cannabis and set a new benchmark in quality and innovation for medicinal-grade starter materials and finished products.
With the approval of a cultivation licence, the company will now begin the development of novel micropropagation and conservation techniques for large-scale plant production.
It will also study a selection of various cannabis cultivars from its bank of genetics, as well as the development of innovative cultivation strategies and protocols to optimise plant quality, performance and potency.
CEO of Trichome Pharma and Managing Director of Trichome Capital, Nicholas Balk, commented: “Receiving AEMPS approval is a significant milestone for the company that marks the culmination of many months of hard work. It’s a really exciting time to be in this industry. I’ve always believed that Spain is the perfect place to build and grow a cannabis business.
“Not only does it possess a world class agricultural sector and optimal climatic conditions for cannabis cultivation, but it also has a rich ecosystem of knowledgeable industry experts and a deeply-rooted culture in cannabis.
“Of course, we’d love to see domestic regulation evolve in the same way other European markets have and trust this will happen in the not too distant future.”
The company, which is a member of the European Industrial Hemp Association (EIHA), has also launched its new website.
Collaboration to conduct research to support the cannabis industry
Open Book Extracts and Biopharmaceutical Research Company will research the full range of cannabinoids.
Open Book Extracts will be leveraging Biopharmaceutical Research Company’s research platforms in order to develop research-backed formulations and products.
The new collaboration is aiming to build up the body of evidence surrounding the benefits of cannabinoids in order to support the cannabis industry.
Open Book Extracts and Biopharmaceutical Research Company will work closely together on preclinical and first-in-human (FIH) dosage forms, to optimisation of formulations for late-stage development and market following clinical evaluation.
They will be developing the most appropriate formulation based on the physicochemical and biopharmaceutics properties of the cannabinoids of interest, the intended route of administration and the phase of development.
Open Book Extracts CEO, Dave Neundorfer, commented: “Current political and economic situations have created non-science-based products that are not serving today’s consumers, and are not designed to fill the research gaps we desperately need to fill to legitimise the emerging anecdotal evidence.
“Companies that base their brands on the research-backed formulations guided by science and develop corresponding products will rule global market share, and recreate how we choose to find therapeutic relief along with relaxation and stimulation.”
The partnership with BRC also supports the study of Delta-9 THC products and formulations, allowing OBX to identify the phase appropriate, optimal products for formulations including Delta-9 THC.
“We are excited to expand our research capabilities through our collaboration with BRC, in particular being able to add Delta-9 THC as a cannabinoid of interest for our formulation research,” said Neundorfer.
Open Book Extracts (OBX) has a 76,000 sqft research and production facility near Durham, North Carolina, and has developed proven methods to efficiently manufacture a broad range of cannabinoids from hemp and natural sources, including CBD, CBN, CBC, CBG, CBGa, CBT, CBDa, CBDv, and THCv.
Biopharmaceutical Research Company (BRC) CEO, George Hodgin, commented: “BRC is pleased to partner with OBX, joining forces to further build the body of evidence to support the cannabis industry.
“It is time we investigate the real science, and develop products for brands that take our culture to the next step. It will take a concerted effort. Developing appealing and effective cannabis-based products requires a multidisciplinary approach in food and pharma chemistry.
“BRC is a one-stop-shop for developing, modifying and improving these new products, and we’re excited to work with OBX to help bring novel, well-studied, effective products to consumers everywhere.”
Over a third of US THC products too strong for legal sale
Despite complying with the Farm Bill, a new study has shown that many US THC products are too strong to legally sell in a cannabis dispensary.
CBD Oracle has carried out a lab study of 53 THC products showing that over a third would be too strong to legally sell in a cannabis dispensary.
The new CBD Oracle report reveals that THC gummies can be over three times as strong as dispensary edibles. The US Farm Bill, introduced in 2018, makes any “hemp” product legal provided it contains less than 0.3 per cent delta-9 THC by dry weight. All but two of the products contained THC within this legal limit.
The report shows that hemp delta-9 products use the specific language of the 2018 Farm Bill to sell high-THC products with far fewer restrictions than edibles in legal states. CBD Oracle states that this has flooded the market with edibles, tinctures and cartridges that wouldn’t clear the higher bar usually used for high-THC products.
It also found that, largely, companies do no age verification, do not test products for safety and do not give customers the dose that they claim to.
Chief research officer at CBD Oracle, Mark Mellone, commented: “Our investigation reveals an industry profiting from a legal loophole, offering gummies much stronger than dispensary edibles with barely a fraction of the oversight.
“We bought products online without ever proving our age and all but one was just dropped at the mailbox. We’re all strongly pro-cannabis, but hemp, cannabis and CBD’s growth (and further legality across the US) depends upon how well we can maintain standards in both products and industry conduct. We need to do better than this.”
For the report, CBD Oracle commissioned InfiniteCAL Labs to analyse 53 of the most popular hemp delta-9 THC products on the market, covering 40 per cent of all brands. All of the samples were analysed for potency, and 10 were randomly chosen for additional safety testing. Oracle also looked into the products from the lab reports to determine whether companies use child-protective packaging or asked for a signature on delivery.
The analysis found that 51 per cent of products are mislabeled, dosages are often very high, 75 per cent of products are not tested for safety, some companies get certificates of analysis (COAs) from non-ISO-accredited labs and that 85 per cent didn’t use online age verification to prevent minors accessing high-THC products.
The analysis also found that hemp delta-9 products contain up to 36.7 mg of THC per serving. For states that have passed adult-use cannabis laws, the most common maximum allowed serving is 10 mg, but some states set the limit at 5 mg. The analysis showed that 34 per cent of products exceed this 10 mg per serving limit, and so wouldn’t be legal as part of state cannabis programmes.
It was further revealed that 51 per cent of products were more than 15 per cent above or below the dosage they claimed. In most cases, they were below, with 45 per cent of all products having less THC than the customer paid for.
In three cases the actual dosage was much higher than advertised, such as gummies supposedly containing 10 mg of THC each actually containing 16 mg.
Despite these concerning findings, CBD Oracle also highlighted that 96 per cent of the products tested fell within the 0.3 per cent THC Farm Bill limit and that all of the products sent for safety testing came back completely clean.
Whilst clean products are a good sign for the industry, CBD Oracle remains concerned that young people are gaining access to products illegally due to the lack of age testing and delivery signatures by companies – stating there is a huge need for further regulatory oversight.
Gillian Schauer, PhD, MPH from the Cannabis Regulators Association commented: “In addition to the consumer safety and youth access issues, from a market perspective, having high THC hemp-derived products creates a parallel marketplace to existing medical and adult-use cannabis markets.
“The barriers to entry for licensees on current state medical and adult-use markets are much higher, in part because of required consumer safety regulations related to packaging, labeling, and testing.
“A parallel marketplace with lower costs of doing business because of fewer safety regulations could certainly undercut existing medical and adult-use licensees in state markets.”
To read the full report please click here.
Cellular Goods submits application for skin brightening patent
The company said its research found that lab-tested cannabinoids improve the efficacy of active ingredients in traditional skin brightening products.
Cellular Goods claims that lab-made cannabinoids can help improve uneven skin tone as a result of factors including ageing, sun exposure and hormonal changes during pregnancy.
The UK-based wellness company Cellular Goods has submitted its first patent application for the use of cannabinoids in skin brightening products. The patent application comes after a series of research projects conducted by the company which found that cannabigerol (CBG) can improve the effectiveness of traditional skin brightening products.
Internal and external factors like hormonal changes during pregnancy and exposure to the sun can cause skin conditions such as melasma and hyperpigmentation that can make the skin tone change and become uneven. There are already a number of products within the beauty and cosmetics industry that claim to produce a brighter and more even skin tone.
Most products in the skin brightening market rely primarily on active ingredients such as Vitamin C, exfoliating acids and hydroquinones that, although effective in tackling melasma and hyperpigmentation, can cause skin irritation and sensitivity.
Cellular goods said there is a need for new ingredients that are as effective as those found in traditional skin brightening products without the uncomfortable side effects.
In an effort to find a suitable alternative, Cellular Goods conducted scientific research to assess the potential of cannabinoids as skin brightening ingredients. The series of research, which involved in-vitro human tissue models, found that lab-made cannabinoids, namely CBG, can improve the efficacy of certain active ingredients found in existing skin brightening products.
“From having skin brightening properties through to helping prevent the signs of ageing caused by UV light exposure and inflammation, cannabinoids have a number of skincare benefits that we are only just starting to understand,” Anna Chokina, CEO of Cellular Goods, said. “The filing of this patent based on our own research is part of our efforts to help unveil the benefits of cannabinoids, as well as to develop science-backed innovations that can improve people’s wellness.”
Cellular Goods has incorporated the research findings into its patent application, ‘Dermal Composition Comprising Cannabinoid and Derivatives Thereof’, filed on 26 April 2022 with the UK Intellectual Property Office. The company said the patent application will form part of a wider patent portfolio driven by Cellular Goods’ research into the wellness benefits of lab-made cannabinoids.
The company produces a range of skincare products including its ‘Rejuvenating Cannabinoid Face Serum’, the UK’s first CBG-based serum to prevent the signs of ageing caused by UV light exposure and inflammation.
“This work builds on our existing research involving lab-made cannabinoids, including the publication of a white paper on the potential benefits that cannabinoids can have for the skin by preventing the signs of ageing caused by UV exposure and inflammation,” said Alexia Blake, Head of Research and Product Development at Cellular Goods. “We are committed to continuing to develop research that will help us better understand the unique benefits of cannabinoids and how to effectively leverage these benefits across our product offerings.”
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