Valois opens pilot unit for inhaled drugs
completed construction of a pilot filling and packaging unit based
at its site in Le Vaudreuil in the Eure area of France, dedicated
to the production of pressurised medicinal preparations for
administration via the pulmonary route.
Valois said it can now not only carry out feasibility and functionality studies on its customers' formulations, but also produce investigational medicinal product using Valois delivery systems.
The Pilot Filling and Packaging Unit is installed in 700 square meters of floor space, 272 square meters of which is occupied by a controlled-environment area.
Valerie Leveque, the pharmacist responsible for the unit said: "Our objective is not production in industrial quantities but making up pilot batches for our customers to enable them to carry their development studies forward up to the Phase II clinical study stage."
Under current regulations, an application must be made for authorisation to open a pharmaceutical facility for each type of product. The consent obtained by Valois covers pressurised preparations using metering valves but, in the longer term, the division intends to extend this approach to include the whole of its product range: nasal pumps, unit-dose devices and dry powder inhalers.
Manufactured valves are currently tested using pure propellants, and pumps with inert solutions. At present it is the product developer's responsibility to carry out testing of these same delivery systems using the formulation it has developed. The pilot filling and packaging unit will enable customers, if they so wish, to delegate this task to Valois.
A dry powder inhaler system currently under development by Valois, is likely to be the first beneficiary of the unit's activities.
