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Natural medicines can vary considerably depending on how they are produced. Seed to Patient is a method where all of the processes involved in the growth and manufacture of a natural medicine are tightly controlled to reduce variability. The benefit for patients is that products proven in clinical studies are reproduced with the same properties year after year, ensuring predictable results.
Seed to Patient involves the application of careful controls to seed selection, propagation, cultivation and harvesting, to produce reliable and consistent raw materials. These raw materials then undergo standardised processes, including extraction and manufacturing, to produce high-quality finished products with assured batch to batch consistency. Clinical studies must then be conducted on those exact products to demonstrate their safety and efficacy for patients.
Our cultivation methods observe Good Agricultural Practice (GAP) which involves working closely with farmers and other partners. There is more to the Seed to Patient method however, including selection of the exact species and standardisation of propagation, cultivation and harvesting. These controls guarantee raw materials with a consistent phytochemical profile.
The Seed to Patient method demands more than the mandatory observation of Good Manufacturing Practice (GMP). Standardisation of all inputs and processes is essential to ensure product consistency from one batch to the next, often referred to as batch to batch consistency. It is achieved through a series of strict controls applied to manufacturing processes including solvents used and extraction methods, through to packaging, storage and transportation of finished goods.
The final stage in the Seed to Patient process is to conduct research and clinical trials to substantiate safety and efficacy of finished products. Clinical study results are validated by publication in respected peer-reviewed scientific journals. Batch to batch consistency of products permits transferability of clinical research data. Clinical outcomes are only relevant to the specific product that has been trialled and should not be used to support different products.