A full range of cGMP spray drying facilities - operating at laboratory, pilot and industrial scale - have been installed at Hovione's active pharmaceutical ingredient (API) manufacturing plant in Loures, Portugal, and are currently being installed at the company's Technology Transfer Centre in New Jersey, USA.
The expansion adds to the spray drying industrial facility - installed at Loures in 2004 - with three additional units, one at lab scale and two others at pilot scale. This gives the company the capability to produce from just a few grams of API for feasibility studies, to full-scale commercial production.
Hovione said the new technology boosted its particle design capabilities. Particle size is a major factor in the performance of a drug product, and pharmaceutical companies are increasingly demanding that this factor is rigidly controlled, batch after batch, in API production.
Although other technologies exist for particle size and morphology control, spray drying is becoming more widely used, largely because of its scaling-up capabilities, which allow production volumes to go from grams to tonnes yet still provide particles with the same size and morphology.
The manipulation of the operational parameters during spray drying offers the possibility to control the design of the particle and its attributes to meet the requirements of final product. Optimal sizing and shaping of particles, together with a variety of encapsulation options, can improve product stability and bioavailability. Spray drying also overcomes micronisation issues associated with conventional grinding and jet milling processes, said Hovione..
The expansion of its technological capabilities is one way Hovione is trying to cope with the increased competition in the European marketplace for API production from companies in Asia, a topic raised by Hovione's CEO Guy Villax at last year's CPhI exhibition.