The Evolution of the European Cannabis Lab
The lethargic legacy model of the contract analytical laboratory is proving increasingly insufficient for the needs of the rapid development of modern pharmaceuticals. Nowhere is this more evident than in promising nascent drug research areas, such as cannabis-based drug applications, explains QNTM founders Justin Ihnken and Connor Murphy, in collaboration with Anthony Macherone, strategic technical scientist at Agilent.
Denmark-based QNTM Labs, is a fully licensed EU-good manufacturing policies (GMP) analytical laboratory taking a fresh approach to the role contract partner labs and the degree of expertise they possess. In contrast to the traditional contract lab model, QNTM Labs favours a value-added holistic method, working in lockstep with pharmaceutical companies throughout the entire drug lifecycle from ideation and discovery to clinical trials and regulatory compliance.
This is important as changes in the regulatory landscape and the growing role of compliant data demand a level of agility and evolution for drug developers that laboratories need to constantly keep up with, explains Ihnken.
“There’s an increased focus on quality data across the entire lifecycle of pharmaceuticals and medical products, which the traditional contract laboratory model is proving to increasingly fall short of. This created an opportunity to reinvent the way that pharmaceutical companies interact with the laboratory services part of the industry.”
Macherone agrees and adds that “data integrity, management, and archival are critical in the modern laboratory and customers are required to comply with an increasingly complex regulatory environment.”
Out with the old, in with the new
QNTM has chosen to have its strategic approach championed by Agilent, a company that also recognises the limitations of the contract lab model when it comes to increasingly complex nascent industries, such as cannabinoid-based pharmaceuticals. From product development to data management, the historical precision of laboratories is becoming increasingly muddled with risks that can seriously affect a laboratory and its reputation.
“The goals and challenges at the heart of the pharma sector require new approaches and new ways of thinking,” says Macherone. “Powerful partnerships of the type advocated by QNTM Labs help drug companies accelerate their processes, safely and compliantly, adding value and helping ensure peace of mind. The future of effective drug [discovery and] development will increasingly rely on collaborations that support efficient asset and resource management and the ability to plan ahead.”
Together, Agilent and QNTM Labs have developed innovative analytical approaches, which have recently been implemented for the analysis of cannabinoid-based pharmaceuticals. While there is reason to believe that cannabinoids may have beneficial properties, much more objective data is needed supporting their potential applications.
“Cannabis-based drug development is interesting because there are hundreds of potentially relevant compounds unique to the cannabis plant,” says Murphy. “At the moment, however, there are limited clinical trial data to substantiate product use cases, which means the laboratory needs to play an even larger role in identifying and measuring critical information surrounding cannabis APIs [active pharmaceutical ingredients]. That's what's going to drive decision making.”
Driving an emerging Europe-led market
QNTM Labs operates a state-of-the-art EU-GMP pharmaceutical facility that offers end-to-end support for developing cannabis-based pharma products. The lab leverages its expert team of specialists in pharmaceutical compliance and natural product chemistry, who understand the complexity of handling a biological pharmaceutical product that may naturally lack stability and be subject to degradation.
This set of unique expertise can help companies during a pivotal moment for a rapidly advancing industry. According to a recent report by Grand View Research, the global cannabis pharmaceuticals market is expected to grow at a compounded annual rate of 104.2% between 2022 and 2028. Due to its regulatory arrangements, Europe is currently the leading region for the cannabis pharmaceuticals market and is home to major manufacturers within the sector.
For enhanced development, QNTM Labs regularly shares knowledge and expertise with Agilent and has explored a variety of methods using Agilent’s ultra-high performance liquid chromatography tools, smart gas chromatography, and triple quadrupole mass spectrometry workflows. The long-term goal is to establish analytical standardisation within the emerging field of cannabinoid-based pharmaceuticals.
“When I look at our partnership with Agilent, we truly do have someone who sees the industry the same way as we do,” says Ihnken. “The support we’ve received from Agilent includes cutting-edge analysis with some of the most innovative technologies in the world. In them, we have a technology partner that is helping us break into new markets and [develop] new analytical methodologies.”
QNTM Labs’ mission is to improve transparency and increase access to robust scientific analyses, working hand-in-hand with global drug manufacturers and pharmaceutical industry stakeholders through analytical testing, contract research, and clinical trial support.
“Our company was founded on the basis of helping fix the holes that currently exist in this industry,” says Murphy. “Even as regulators working to establish standards, there is still so much complexity and nuance to meeting requirements. We pride ourselves on is sitting down with our customers and helping them understand the requirements their products need to meet as a manufacturer of cannabis-based pharmaceuticals.
“Our team has decades of experience on both the manufacturing and analytical side of the industry and deeply understand the frustrations that exist in bringing a drug to market – which is what our solution tackles head on.”
Nurturing the green shoots of growth
As Europe’s cannabinoid-based pharmaceuticals businesses continue to grow and develop, so will the need for collaboration with lab testing partners and the need for strategic guidance. QNTM Labs has placed itself at the forefront of analytical capabilities by using cutting edge analysis and analytical methodologies, that drive innovation and deliver results.
What is clear is that the market for cannabis-based pharmaceuticals will continue to grow and QNTM Labs will be helping its customers maximise their opportunities, now and in the long term.
Disclaimer: Agilent products and solutions are intended to be used for cannabis quality control and safety testing in laboratories where such use is permitted under state/country law.