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Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application (SAMPA).

Periodic Reporting for period 4 - SAMPA (Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application (SAMPA).)

Reporting period: 2019-11-01 to 2020-04-30

The key objective of this project is to scale-up a novel solid oral delivery technology, SmPill®, which is based at the initial stages of the process on a nano-emulsion type manufacturing process and use PAT tools to help inform the process and embed quality control into the product from the start.
SmPill® is an integrated oral drug delivery platform technology that integrates solubility, permeability and stability enhancement with targeted gastrointestinal release. SmPill® manufacturing requires an advanced manufacturing process that involves novel custom-made equipment.
The intention is to scale current pilot scale process from current pilot scale to meet the requirements of next clinical phase of development (Phase III) and support the supply of commercial product.
ST-0529 is a proprietary SmPill®-enabled colon-targeted formulation of cyclosporine advancing into late stage clinical development for the treatment of ulcerative colitis. ST-0529 is Sublimity’s lead product into the market with this new technology and the focus of this project.
Through the SAMPA project Sublimity is working with a number of European companies to advance the scale up of the SmPill® advanced manufacturing process, including:
• a German advanced engineering and equipment manufacturing company to design, manufacture and develop customised equipment to meet Sublimity’s specifications
• an Irish SME focused on chemical engineering solutions to permit incorporation of an upstream Process Analytical Technology (‘PAT’)
• an Irish SME focused on developing and utilising PAT instruments to monitor and control downstream processing
To date within the project Sublimity has completed a number of activities of the work plan, including:
• Identification of the Critical Processing Parameters (CPPs) of this novel process which helped inform large scale equipment design
• The performance of a number of process characterization studies with the help of pre-selected PAT tools and a range of analytical methods to define large scale equipment unit operations and further corroborate the findings in relation to the identified CPPs
• Identified a range of PAT tools to help control the scaled up process in-line and off-line
• Developed a plan for the integration the PAT tools into the large scale equipment to ensure monitoring and control of the process
• Validated the process and shown consistent quality and reproducibility from batch to batch
• Performed ICH stability studies on key batches to ensure product quality
• Identify a technical path to further improve product shelf-life on scale-up
• Assessed clinically through whole blood and colon tissue analysis that scaling-up the coating process had no impact on clinical readouts
Ulcerative colitis (UC) affects 1 million people in Europe, 1.1 million in the US and up to 1 million in the rest of the world. More than 50% of patients have disease with moderate to severe severity. The only approved option for these patients are biologic drugs which are administered by injections, have the risk of serious side effects and which cost up to €25,000 per annum. Therefore, there is a clear socio-economic benefit to successfully bring the ST-0529 product to the market.
Sublimity developed ST-0529 as an oral, efficacious, safe and cost-effective alternative to biologics. ST-0529 is enabled using Sublimity’s proprietary, nano-emulsion drug delivery platform, SmPill®.
The advancement of this product through the clinical pathway into the commercialisation stage is enabled among other contributors (e.g. safety and efficacy) through successful scale up of the manufacturing to allow commercial supplies. Thus the SAMPA project plays a key role in allowing Sublimity advance the ST-0529 product to the market.
Additionally, Sublimity has a number of other SmPill®–based products in its pipeline to treat diseases of the gastrointestinal tract and the advancement of this novel manufacturing process will open an avenue to bring these products to the market.