DANCANN PHARMA A/S Dancann Pharma A/S provided positive insight on the progress of cannabis bulk product (the "Product" or "Cannabis Flos") approval from its EU-GMP facility, Biotech Pharm1. DanCann Pharma has established a new benchmark in the cannabis industry by completing additional microbial testing in conjunction with a microbial suitability and verification study. Results from the testing showed levels 5,000 times lower than the legal requirements.
To achieve this, DanCann Pharma first validated its testing during a suitability study for microbiological testing, which yielded satisfactory results. Actual testing was then done in accordance with validated EP and USP methods for microbial examination of non-sterile products to confirm the purity of the Product. The tests conducted included Total Aerobic Microbial Count, Total Yeast and Mold Count, Bile-Tolerant Gram-Negative bacteria, Escherichia coli, and Salmonella Spp.
The results of these tests have reconfirmed DanCann Pharma's previous claims that its Product is exceptionally pure and free from any contamination, even without the use of radiation. DanCann Pharma's results for TAMC and TYMC are 5,000 and 50 times lower than the legal requirement, respectively. This is a distinctive characteristic of DanCann Pharma since other manufacturers often resort to post-processing methods and steps, such as irradiation, due to their conventional production techniques.
DanCann Pharma produces their biomaterial using the best practices from the pharmaceutical industry in combination with advanced environmentally controlled cultivation technology and vertical cultivation. No soil or other media is being used, but a specially developed system that adds the necessary fertilizers and nutrients. The automated cultivation processes and minimized external product contact have created significant results so far.
It is important to note that the microbial suitability study verified that the testing and methods used are in accordance with European Union Good Manufacturing Practice standards. Regulatory agencies, such as the Danish Medicines Agency, require this type of testing to ensure that manufacturers are adhering to GMP standards and producing high-quality products. Therefore, DanCann Pharma's completion of both the microbial suitability study and subsequent testing demonstrates their commitment to producing a safe and high-quality product for patients without additional processing steps such as irradiation.
By being able to avoid the irradiation step entirely, DanCann Pharma is able to conserve and preserve the valuable ingredients and active components found within the flower, while reducing significant post-processing costs. In addition, several markets and customers have opposition towards of irradiation threated products, including states in Germany.
