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Dec 20, 2018 | Blogs, Food / Beverage | 0 comments
Welcome to the first in a series of blogs from the cannabis team at SCIEX, designed to bring you up to speed and put you in the lead of the recently legalized cannabis market in Canada.
The Canadian cannabis market has taken the plunge into relatively unchartered waters. On October 17, 2018, the Cannabis Act came into force making Canada the second and largest country with a legal national marijuana marketplace. This move will not only revolutionize the market in Canada but will become the test case for other countries that follow. The world is watching, and the stakes are high!
The Journey Through Health Canada’s RegulationsSo how did we get here? Cannabis was banned in Canada in 1923 until regulated medical cannabis became legal in 2001. After he was elected Prime Minister in 2015, Justin Trudeau initiated his campaign pledge to keep marijuana away from underage users and reduce related crime. In June 2018, the Senate passed the ‘historic’ Bill C-45, otherwise known as the Cannabis Act.
It is estimated that 19% of Canadians consume cannabis, which much higher than the 4% worldwide average. It stands to reason that the government wants to control this growing market and leave behind what some have coined as a ‘failed model of prohibition.’ The goals are very clear:
The Act provides a strict legal framework for controlling the production, distribution, sale, and possession of cannabis across Canada. The current program for accessing cannabis for medical purposes will continue under the new Act and licenses will be transferred.
A Big Shift for The Cannabis Supply ChainAs medical cannabis has been legal for 17 years, authorized producers are already familiar with Health Canada’s testing standards, but what does a fully regulated landscape look like and how can licensed Canadian analytical labs (or those applying for a license) stay ahead of the curve?
As we have seen, things won’t change overnight from a buyer perspective. The hope of walking straight into a shop from October 17 to pick up their favorite blend has already been dashed by most Canadians. The biggest constraint is the supply chain’s ability to meet this new legalized demand; the question is why?
Firstly, the 120 federally licensed producers in Canada need more time to scale up, and there are many more applicants under the new Act waiting for their licenses to be issued. It will take time for production to ramp up to meet demand.
Secondly, cannabis needs to go through highly regulated processes between the producer and the consumer to protect public health and safety. Industry-wide rules and standards for producers of cannabis cover:
Producers need to check local laws in their province.
What Does All This Mean?In short, cannabis products need to meet the grade for quality and safety. The way that the government is controlling this is through strict analytical testing, and this is where SCIEX comes in. We support licensed analytical testing labs, regulatory laboratories and licensed producers that need to perform a wide variety of tests to regulated standards with sophisticated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) solutions.
Read the next blog in our series to find out more about the required tests and how SCIEX can help.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
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