Enabling Technologies - Prosonix, the leading company in proprietary pharmaceutical ultrasonic particle engineering technologies and added value ultrasonic process chemistry solutions leverages its intellectual property and sonoprocessing equipment to deliver sustainable value to customers. Based in Oxford, UK, a team of chemists and engineers combine to give Prosonix a multidisciplinary approach to solving complex problems of customers in pharmaceuticals, fine chemicals and minerals processing by employing the technology for the "Complete Crystallization Control" of products, processes and unit operations. CHEManager Europe spoke with David Hipkiss, Prosonix CEO, about this emerging niche market, the developments of the company and the business climate.

CHEManager Europe: Who are your main customers, what companies typically apply your technologies?

D. Hipkiss: The business has changed a little bit over the years. We are working with all people in pharma actually; ­innovator, speciality and generic. We have a number of opportunities working outside of the pharma industry in the likes of cosmetics, energy and natural products. But they only tend to be considered, if the technology is a slam-dunk, a good fit.

You said that business has changed. What was it like in the past?

D. Hipkiss: Historically some of our very biggest projects have been in minerals processing. We haven't done anything like that proactively for a very, very long time. Although I will say that one of our current projects involves catalysis. And instead of using the equipment and the technology for crystallizing, we are actually using process intensification via aiding dispersion and in-situ wet milling. The applications of the technology are still broadening, and where there is good opportunity to make money, we will follow them.

Do you also work with fine chemicals companies?

D. Hipkiss: Through choice we have tended not to work with the typical fine chemical companies. Number one, we have enough business with our core customers elsewhere, whereby we can construct long term business relationships and can get reach-through arrangements such as royalties and licensing, which is very difficult to do with the likes of a fine chemical company. Furthermore, uncontrolled exploitation of your technology can lead to its value becoming a little bit commoditized; we need to make sure we have an element of control over that.

Prosonix technologies can be applied across the pharma life cycle, particularly emergent into two discrete segments. Can you give us a brief overview of the main areas?

D. Hipkiss: The first segment, standard particle engineering is largely based around the use of the Prosonitron reactor for controlled crystallisation of pharmaceutical API. This is a simple retrofit technology typically for large-volume drug production. And yes, we believe it can become the preferred standard for manufacture. What are people interested in there? Reducing cost of goods, improving process robustness and improving reliability. The second segment, the advanced side is really where we are looking at the other types of technologies, which we call DISCUS, SAX, UMAX, and particle rounding technology (PRT), etc. That is where we are engineering performance enhancing features into the crystals themselves, such that they have a transformational benefit in the formulation. Thus, one is cost saving, one is enabling. On occasion we deliver both.

What are the key process benefits of sonocrystallization?

D. Hipkiss: The key benefits of sonocrystallization include control of particle size, shape, crystallinity, and polymorphism directly from solution, as well as an improved robustness in batch consistency, filtration, isolation and drying. We can also eliminate the need to use physical seeds and critically, milling and micronsisation. As a consequence of that the drug product, which is subsequently formulated, is better and more reliable, more stable, and critically GMP is improved. It also meets the definitions of the ICH Q8, the PAT and the new QbD directives emergent from the FDA.

Recently, you announced collaborations with Pfizer and Sandoz. What is the subject of these agreements?

D. Hipkiss: We have worked with Pfizer for many years. Pfizer has successfully demonstrated our technology at small scale, kilo scale, pilot scale and they have now bought a commercial scale system for installation in their key new product introduction facility in Ireland. The system we have provided is a multiple, mobile system capable of working on reactors up to 4000 litres which is full commercial scale.
With Sandoz Aeropharm we have a public arrangement to assist them in the manufacture of difficult to make inhaled products. The generics opportunity is one of growing and significant interest to Prosonix.