Merrion’s new R&D facility located in Citywest, south Dublin, Ireland is a state-of-the-art facility designed to accommodate space and capacity requirements essential for technology and product development. Launched in October 2009, the Citywest facility is ideally suited to Merrion, which holds key expertise in developing and scaling up drug product formulation.
The facility was constructed between 2002 and 2003 at a cost of €3.75m. It is equipped to produce a range of class III drugs and aid Merrion with its further expansion plans.
The Citywest facility occupies a total floor area of 29,500ft2.
The layout includes 6,000ft2 of office space, a 6,500ft2 formulation process development area, a 4,000ft2 space for analytical laboratories, a Class D clean room, 21 processing rooms, two GMP labs, one development lab and one feasibility lab.
A 2,100ft2 warehouse and nearly 3,700ft2 of free space for future expansion are also provided in Merrion’s Citywest facility.
The facility is designed to introduce new products at the lowest risk and fastest possible time. Designed to work with multiple actives, the facility can support product development across various stages of development including pre-clinical proof of concept phase, Phase I and Phase II clinical product development and registration batch manufacture.
It can develop solid drug products for oral dosage in a range of batch scales and also work on development and clinical product manufacture at the same time.
The facility has an Irish Medicine Board (IMB) licence to develop investigational medicinal products for human trials in accordance with the EU Clinical Directive for investigational medicinal products. It has also been granted a US Food and Drug Administration audit–pre-approval
The facility will adopt tablet compression as a core technology to develop oral drugs and biologics. Specifically, drugs will be produced based on the Gastrointestinal Permeation Enhancement Technology or GIPET™ technology, a commonly used technology by Merrion.
Due to its multi-active features, Merrion Citywest is ideal for adopting GIPET technology, which allows better oral absorption of a broad range of class III drugs.
GIPET is a technology platform that stimulates distribution of poorly permeable compounds into the human bloodstream after a drug has been orally administered. The technology, using Generally Regarded as Safe (GRAS) rated ingredients and oral formulations of patented absorption enhancers, activates the formation of micelle, which enhances drug absorption.
In a database consisting of over 30 poorly permeable compounds, GIPET demonstrated the ability to enhance compound absorption by about 200 times. It offers superior reproducibility and safety profile in all types of drugs and leads to the development of low-risk new oral products in the shortest time to market.
Using GIPET technology, the facility will manufacture either its own drugs or partner with fellow pharmaceutical companies to manufacture oral GIPET formulations of their products.
Four internal product development programmes based on this technology are in the pipeline. This includes Orazol (MER 101), Almerol (MER 103),Acyline (MER 104) and MER 102, which are meant either for oncology indications, osteoporosis treatment, prostate cancer or prevention of blood clotting.
Aside from these drugs, the facility will also develop oral forms of Novo Nordisk proprietary GLP-1 receptor agonist.
In addition, it will undertake two oral drug delivery research programmes on an undisclosed Ferring compound in collaboration with Ferring Pharmaceuticals.
The facility’s GMP process area accommodates a state-of-the-art pilot and pivotal scale equipment that supports low shear blending and granulation, high shear blending and granulation, fluid bed granulation, coating and drying, hot melt granulation, tablet compression, capsule filling, pan coaters for tablet and capsule coating, solid dispersion and technologies for solubility enhancement, spray drying, bottle packaging and blister packaging.
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