Pfizer’s API unit to use Prosonix' Prosonitron
Crystallisation, which is among the most commonly used separation and filtration techniques in the drug industry, is an extremely complex process that is dependant on a disparate range of hard-to-control variables.
Prosonix’ technology uses power ultrasound to tightly control the process, enabling the precise production of high purity organic and inorganic microcrystalline chemicals.
The system, which can be applied to both excipients and active pharmaceutical ingredients (APIs), is designed to lower manufacturing costs, increase productivity by reducing batch failure and improve safety of operations.
Under the supply agreement, financial terms of which are not being released, Pfizer will use the Prosonitron system to improve the crystallisation of a number of APIs as part of its ongoing efficiency drive.
As Prosonix CEO, David Hipkiss told in-PharmaTechnologist: “Standard crystallisation is ubiquitous in pharmaceutical manufacturing as a key means of isolation and purification and most crystallisations are uncontrolled by their very nature.
He went on to say that, in contrast with currently used techniques, the firm’s “ultrasonic particle engineering technology allows unprecedented control of size, shape, polymorphs, and a range of key physicochemical properties of API’s and excipients.”
Hipkiss explained that Prosonix’ proprietary process and reactor technology “eliminate[s] the need for micronisation and all of the problems associated with it,” and added that such benefits translate into quantifiable primary and secondary manufacturing advantages.
He added that the system also lends itself to stable continuous processing applications. “In a non-pharmaceutical application the largest system to date is, and has been, processing 70,000 kg per hour of process fluid 24 hours a day for the last 3.5 years with no failure.”
In addition to its relationship with Pfizer, Prosonix is, according Hipkiss, “working with, or are in discussions with almost every major pharmaceutical and leading speciality pharmaceutical companies in the world. We have been selective in our choice of generic partners to date.”
He singled out inhaled therapeutics as a key area for the firm, adding that there are “a number of very exciting opportunities in oral products, particularly those which are difficult to crystallise or are poorly soluble.”
Simon Davidson, new product team leader at Pfizer global manufacturing, said that: “Sonocrystallisation technology offers an additional tool to augment existing techniques for API crystallisation and in-situ selection of specific API physical characteristics.”
