By Evolve Ltd.
Evolve shapes guide to regulatory compliant medical cannabis production
Luqa, Malta: – Life sciences environment specialist Evolve Ltd (Evolve) has recognized the rapid development of the ethical cannabis industry by producing a series of guides to cultivating, testing and licensing the plant successfully for pharmaceutical, nutraceutical and other applications.
In an article for Malta’s Open Access Government online journal (see Resources), Evolve’s Managing Director, Christopher Busuttil Delbridge, identifies two key challenges for would-be ethical cannabis producers; consistency and quality control (QC). Both are significant hurdles in the complex regulatory approval process.
Ensuring regulatory compliance for Medical Cannabis
All of the clinical trial requirements for drugs or vaccines apply to medical cannabis; specifically potency, purity, efficacy and identification of side effects to protect patient safety. These can only be ensured through QC testing, supported by rigorous production procedures, as defined by Good Manufacturing Practice (GMP) standards, as laid out in region-specific Pharmacopeial compendia.
“For Cannabis to be labelled ‘Medical Grade’ there is absolutely no difference from any other pharmaceutical form. And the sooner traditional manufacturers move from their well-honed agricultural mindsets to face the new reality of GMP regulations, the more solid their investment and business plan becomes,” Mr. Busuttil Delbridge points out.
“No Medical Cannabis processing company anywhere along the value chain which is worth its salt can survive without strict adherence to a Quality Control mindset,” he emphasizes.
In the case of Medical Cannabis, the first challenge is consistency: the ability to grow the chosen strain of cannabis sativa with reproducible active ingredients. The Evolve guide says this can be achieved by various methods including:
- Using the same ‘mother plants’ and cloning (creating an exact genetic replica) new plants from them.
- Cutting only the top bud (since different ‘flowers’ along the stem contain different ratios of the required active ingredients).
- Controlling the variables of the environment, making adherence to Good Agricultural Practice methods (GACP) essential for anyone growing cannabis for medical formulations.
- Rigorous QC testing.
Ensuring quality control
Once the ‘raw material’ is ready for harvesting, it must undergo various trimming, drying and other processes to turn it into a final product, such as powder, desiccated extract, oil, or tincture, ready for pharmaceutical, cosmetic, nutraceutical, or food additive.
There are many active ingredients in the cannabis sativa plant, of which the most significant are tetrahydrocannabinol (THC), cannabigerol (CBG) and, most significantly for most applications, cannabidiol (CBD). The most significant QC assays are in ensuring effective isolation and consistent potency of these APIs, which must include testing for any pesticides or fertilizer additives used during the growing process, along with testing for heavy metals, aflatoxins (indirect measure of fungal contamination), microbiological contamination and solvents used in extraction processes.
“This basic non-exhaustive list of tests is unfortunately still not coordinated between various countries, and even when they are, the limits of detection and allowable limits do not always tally. It is an accepted fact that Medical Cannabis is a relatively young industry. This, combined with the facts that we are dealing with a natural product which is very complex by nature, makes the role of any company setting up its QC structure a headache,” Evolve comments.
Yet with rapidly developing laws and regulations governing what is becoming a significant industry, this ability is going to be vital to provide consistent and quality assured cannabis-derived products in an increasingly competitive marketplace.
Sophisticated laboratory methods
The increased need for stringent and compliant quality control and quality assurance in the burgeoning cannabis industry are placing new emphasis on use of sophisticated analytical instrumentation, such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS) and Inductively Coupled Plasma (ICP), all of which require extensive laboratory experience, with training and deep understanding of analytical chemistry.
“The methods and semi-automation of these technologies are coming to the fore. The use of more intuitive software interfaces and a progressively digital-ready workforce lower the threshold of the required learning curve,” says Evolve’s MD.
“It is evident that the global cannabis production industry requires significant change and challenges must be overcome around analytical testing to provide consistently high-quality products. A well set up QC laboratory can alleviate this challenge,” he continues.
Evolve believes cannabis producers will increasingly look to outsourcing or consultancy to set up or upgrade their growing, processing, and QA testing to meet required GMP and other standard.
“Scientific consulting firms such as Evolve Ltd have done it all before and have all the required expertise to make this a pain-free experience for anyone investing in this process, especially in the European and sub-Saharan African countries where Evolve operates,” Mr. Busuttil Delbridge concludes.
About Evolve Ltd.
Evolve Ltd, is a Malta-based solution provider and project integrator operating in the Mediterranean and sub-Saharan African region. Servicing all scientific workspaces Evolve professionals offer Design, Consultancy, Sourcing and Maintenance services to healthcare and industrial communities. Having been the ones to introduce NGS technology in Malta, Evolve is best positioned to continue building on its knowledge and services to further scientific advancement in this sector in Malta too.
Empowered specialists give faster and more accurate results for the benefit of patients.
Evolve offers a holistic service that draws on four principal areas of expertise, in the design, installation and equipment, personnel training and maintenance of laboratory and research facilities and equipment.
Evolve Ltd. is part of the Attard & Co. Group of Companies and traces its origins to Attard’s setting up in 1956 of Medical and Scientific Equipment and Supplies (MSES) to cater for its scientific products. During the 1990s, under the leadership of Christopher Busuttil Delbridge, Evolve’s current Managing Director, MSES changed its business model, centered on a vision to become a recognized, award-winning, world-class thought leader and influencer on the international scientific and healthcare laboratory market.
In 2006, following Malta’s accession to the EU, MSES Department was rebranded as Evolve Ltd., an independent Attard subsidiary tasked with serving the scientific community. Within five years, it had developed three operating departments: Medical & Diagnostics, Scientific Services and Technical Services.
Evolve currently employs some 30 people, mostly scientists and technical experts.
Further information at: www.evolveltd.eu
Click on Ensuring Regulatory Compliance for Medical Cannabis to read original Open Access Government article.
Click on Evolve Newsroom to see further news and events from Evolve Ltd.