The contract manufacturing organization (CMO) said the tech, which will be installed at a purpose built Portuguese facility, will produce active pharmaceutical ingredients (API) and intermediates in accordance with SafeBridge category 3 standards for development, clinical and commercial applications.
Doug Hecker, responsible for business development within the Particle Design Business (PDB) told in-PharmaTechnologist that: “Aseptic spray drying is a perfect, cost effective alternative to aseptic lyophlization for a number of products,” adding that the move “is a natural expansion of Hovione's Particle Design Business.”
He went on to explain that: “The pharmaceutical industry is looking for technologies to solve the growing problem of new chemical entities (NCEs) with poor solubility or bioavailability.
“This problem, along with the misconception that spray drying was not suitable for labile compounds, is due to chemists and formulators historically going after the most stable form of the API, which was the crystal form.
“Unfortunately, the crystal form can often result in the material having poor solubility, inadequate bioavailability or inferior formulation attributes. Thus, as spray drying typically generates the amorphous form, it was not the technology of choice and as such lyophilization became the standard in the pharma industry.”
“Scientists are now accepting spray drying as an enabling and commercially viable technology for all materials, including proteins and peptides [that] if done correctly, [generates] more consistent and homogeneous products.”
Hecker added that, despite these benefits the firm does not expect spray drying technology to become common in the manufacturing operations of pharmaceutical or fine chemicals firms because “it is expansive and few compounds mandate [its use].”
“However when you require amorphous particles, co-processed API, greater precision in particle size and other physical attributes, spray drying is an excellent enabling technology.”
He went on to cite inhalation drugs as one of the key drivers of demand, explaining that “spray drying is far more elegant and scientific than the jet-milling brute force. When you need tons of sterile material then spray drying is less costly than freeze-drying.”