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Jun 3, 2019 | Blogs, Food / Beverage | 0 comments
Welcome to the second 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.
In the first blog, we introduced the Cannabis Act and what it means for the industry. Here we explore product safety and the related analytical testing requirements by answering your common questions.
Why Is Safety up There as a Top Priority?‘Protecting public health and safety by allowing adults access to legal cannabis’ is one of three top priorities of the Act. Regulation aims to ensure that cannabis is safe by eliminating potentially dangerous cultivation and processing practices. Strict rules and standards for producers cover, amongst other things, the types of cannabis products allowed for sale, packaging and labeling requirements, prohibiting the use of certain ingredients and good production practices.
How Will These Safety and Quality Standards Be Monitored?The short answer is through testing. There are strict rules throughout the supply chain from cultivation to sale, and rigorous testing has been federally mandated by Health Canada before cannabis products are made available to the public. In other words, legal cannabis products must meet the grade.
What Tests Need to Be Done and Why?Relative to other industries, safety and regulatory standards for cannabis testing are in their infancy. In Canada, there are already rules for testing in place for medical marijuana, but these are expected to become more comprehensive and stringent.
Laboratories certified for analytical testing must conduct all tests using validated methods on every lot or batch of cannabis to ensure requirements are met. Testing depends on the cannabis product class, but will typically include potency, purity, and safety.
Different provinces and territories will set acceptable limits through localized cannabis regulation.
How Can Testing Help Improve Supply?As cannabis sales shift to licensed outlets and more producers receive their federal stamp of approval, the demand for testing services is expected to rocket. Commercial cannabis testing is very competitive, and legalization will put pressure on the scientific community – who need the right instruments and methods to stay ahead of the curve and ahead of demand.
Using liquid chromatography-tandem mass spectrometry (LC-MS/MS), SCIEX has pioneered standardized testing methods to analyze potency, terpene, pesticides, and contaminants to Health Canada regulations.
To find out how LC-MS/MS helps analytical testing labs, regulatory laboratories, and licensed producers to clear the bottlenecks and supply safe, legal cannabis products to the Canadian market, check out the next blog in our series.
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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