~ How in-process testing leads to quicker turnarounds ~
The medicinal cannabis market has grown significantly in recent years and is estimated to be valued at $50 billion by 2030, driven by widespread legalisation across multiple jurisdictions. It is, however, important to ensure products are tested to meet the quality standards of the market’s locality. The pace of testing, however, isn’t necessarily meeting the growth rate of the industry. Here, Beccy Bell, Associate Director of Laboratory Services at testing and regulatory consultancy Broughton, explains how in-process testing can quickly meet the demand of cannabinoid growers.
In-process testing forms part of a routine check in the production process. Samples are taken to assess the THC or CBD content as expected. As the market continues to grow, medicinal cannabis producers face increasing pressure to deliver consistent, high-quality products while meeting strict production timelines. This includes variability in cannabinoid content, inefficiencies in testing processes, and delays in receiving actionable data. This can all adversely impact workflows, profitability, and market entry.
Cannabis is a Schedule 1 controlled substance. Therefore, it is subject to enhanced controls and can only be handled at facilities holding a Schedule 1 controlled drugs licence.
Ensuring that testing meets high quality standards, as set out in the British Pharmacopoeia in July 2024, and is done in a timely manner is difficult for the medicinal cannabis market. There are limitations on the facilities that are authorised to handle Schedule 1 substances meaning that making sure testing is done quickly enough to meet demand is challenging. In addition, while in-process testing is typically a reduced suite of analysis, it can be used to detect unexpected changes in the cannabis flower, providing a quality control check within a shorter timeframe.
One way of addressing this is for growers to work closely with contract research organisations to do in-process testing. In-process testing is typically a reduced suite of analysis that is used to detect unexpected change. Both the grower and the testing organisation need to be transparent about sample preparation and tests carried out by either party to ensure the process is smooth and efficient.
Cannabis growers who have lab capacity must establish a plan when they are harvesting. The Contract Research Organisation (CRO) needs to assess its ability to meet the target concentration set out by the grower. This involves the testing organisation working with growers by sharing dried flower preparation instructions to start the extraction. These are then sent to the CRO for analysis.
The process allows for more regular testing throughout the growth cycle which helps assist in determining the optimal harvest time, which can help reduce the downtime in production.
Furthermore, analysis demonstrating the evidence of a flower’s properties is a collaborative process. The CRO will want to see the repeatability and reproducibility of the extraction performed by the grower – similar to the acceptance criteria used in pharmaceutical analytical method transfers.
The medicinal cannabis market continues to evolve and while the plant material will always be the starting point, Broughton is discussing with its clients about the next phase including extracts, oils and finished products. The potential for growth in the industry is positive, reinforcing our position as the industry’s innovation partner.
With its in-process testing offering and Schedule 1 License, combined with its familiarity with Pharmacopeia and 15 years of GMP compliance, customers can receive THC and CBD levels in a cannabis plant in 48 hours, allowing growers to make quick decisions regarding their cultivation process. All in-process testing is conducted simultaneously, as Broughton stands ready for samples to arrive to ensure that tests and results can be conducted within this timeframe.
For quick turnaround in cannabis testing, with an assistive platform that allows actionable insights into cannabinoid trends, along with the batch release testing and in-house stability studies, get in touch with Broughton today to find out how they can help bring your medicinal cannabis product to market faster.