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Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications

Periodic Reporting for period 1 - USODA (Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications)

Reporting period: 2015-06-01 to 2015-11-30

FORMAC Pharmaceuticals NV, pioneer in Silica based drug delivery, is developing and positioning Ordered Mesoporous Silica (OMS) carriers for the formulation of complex small molecules that suffer from solubility issues. FORMAC's OMS formulation platform enables solid oral dosage forms with excellent physical and chemical stability and unprecedented loading capacity and enhanced bioavailability. Despite numerous promising early successes and results based on a “fit for purpose” scale approach, further commercialisation has been hampered by perceived uncertainties related to the feasibility of scale-up, cost effectiveness of OMS at larger scale and the scale-up timeline.

The USODA project (Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications) aimed at further improving the cost of goods profile linked to the OMS synthesis and assess scale up opportunities.
This project conducted with academic and industrials partners focused on yield increase, decrease in raw materials consumption and optimization of process steps.
As a result of the USODA project, a 76% reduction in the manufacturing cost of OMS at a 1 kilogramme scale was achieved. The material resulting from this new synthesis process was tested for pharmaceutical performances and proved to be similar to the pre USODA material.

In parallel, market assessment through a survey with key stakeholders (pharma and generic companies) has been conducted to position OMS in terms of pricing strategy. Based on the new cost of goods calculation and potential selling price, a clear way forward towards scale up strategy and timing has been defined.
The USODA project provided essential information on the viability of Ordered Mesoporous Silica Drug Delivery. With a process leading to an increase in yield of 168%, better processing steps and potential routes for further improvements, the OMS scale up trajectory at commercial scale is validated. The company also capitalizes on research agreements that could unlock the decision to invest in large scale production.