UTT BioPharma consists of, and is connected with, professionals within the pharmaceutical industry as well as specific entities who have adapted the industry technology standards and requirements for the production of medicinal cannabis products of the highest quality. The specific areas of technological consulting which can be advised upon are upstream, downstream and product delivery processes:
To assess and monitor the cultivation of Botanical Raw Material (BRM) introduced in pharmaceutical development. Production of BRM must comply to the industry guidelines for herbal products set by local and international regulatory committees e.g. World Health organization (WHO), International Conference for Harmonization (ICH), EMEA, FDA, TGA, and others.
International guidelines, particularly relevant for the production of cannabis BRM e.g. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for medicinal plants and ICH Q7 Good Manufacturing Practice Guidelines for active pharmaceutical ingredients. These guidelines should be the premise for a quality management system for companies wishing to operate in this area. UTT BioPharma can provide fully compliant and improved methodologies, protocols, standard operating procedures (SOPs) and batch records for traceability purposes and to achieve a robust and standardized process of manufacturing for high quality BRM.
The use of state of the art technology and automated systems for cultivation practices such as nutrients intake, pH, temperature, conductivity and humidity control to ensure that the process of manufacturing meets the highest industry quality standards.
Introduction of newly made or assessment of existing analytical and testing procedures for intermediates and final products. Industry requirements suggest to produce BRM with consistent levels of compounds within a defined expected range and levels of: herbicides, pesticides, fungi, endotoxins, mycotoxins, heavy metals and bacterias, which must be lower than the limits specified on the American Herbal Pharmacopeia (AHP) Cannabis Inflorescence Therapeutic Compendium.
Genetic selection and classification of strains based on quality, the presence of certain specific compounds and yield of compounds of interest. Plants are selected from seeds and cloned from mother plants chosen based on quality attributes to achieve genetic repeatability and decrease strain variability. Specific plants are selected for particular downstream processes, largely depending on the levels of compounds present in particular strains, to ensure efficient and maximize yield of targeted compounds.
Detailed instructions for harvesting (depending on flowering period of selected plants), curing, handling, storage and preparation procedures of BRM for consequent downstream process steps.
Preparation, development and installation of the newest and most efficient technologies for the extraction, fractionation and purification of compounds from BRM. The system design for BRM purification should include mixers, grinders, heating-chambers for decarboxylation, filter-press, rotary extractors, ultrafilters and chromatography columns. Non-toxic buffers and solvents (e.g. carbon dioxide) should be used during the processing of the materials.
Technology transfer includes implementation and setting up of original methods of manufacturing for new facilities and manufacturing systems at both lab, pilot and large scale. Methods of manufacturing or recipes are designed to comply with pharmaceutical quality management system guidelines (ICH Q10). Commissioning, installation and qualification of facilities must be provided as part of plant and process validation. In order to achieve successful pharmaceutical development and marketing authorization, it is a requirement to comply with current Good Manufacturing Practices (cGMP) and henceforth to produce high quality medical-grade products.
Re-design, adjustment and optimization of downstream processes to improve robustness, purity, output yield and efficiency, and setting contemporary examples for the industry to follow. This include training and mentoring programs for plant bio-technicians and managers to increase productivity, teaming, leadership and upskill their current expertise in the field.
Application of quality by design principles. Setting up protocols for on-going continuous process verification of processes and the possibility of generating newer technologies. This can open up multiple revenue streams through patenting and henceforth licensing agreements.
Creation and design of newest preparations and formulations based on bioinformatic breakthrough with a given possibility of generating newer products for target diseases. This can open up multiple research avenues, revenue streams through patenting of processes, formulations and henceforth licensing agreements.
The formulation of multiple methods of delivery that would be suitable for the medical practice, as well as ideal for delivering optimal dosage levels.
Determining suitable drug delivery methods for the product being formulated, based on active components, and advising on increasing pharmacokinetic profile and efficacy of drugs based on the target disease.
Conducting surveys within professional networks affiliated with UTT BioPharma to determine preferences of administration (specifically medical professionals), and incorporating these opinions onto the product design.