CPhI: Hovione expands particle design services
Irish site key to spray drying capabilities
Hovione has announced the expansion of its particle design services to solve issues of poor bioavailability, patient acceptability and optimal delivery for non-oral routes of administration. The company toolbox now includes crystal design, particle size reduction to micro- or nano-scale and amorphous solid dispersions from bench to commercial scale.
“About ten years ago, we stumbled on a business no-one knew existed,” said Guy Villax, CEO of Hovione during a press conference CPhI Worldwide 2012 in Madrid. “We call it particle design, in other words adding physical attributes to APIs.”
The company has now completed over 100 commercial projects in the field; in reality, it has actually already done particle design in different ways for some 50 years, Villax added. It has, for instance, worked with APIs that needed to be micronised into cream form or targeted at lung diseases. It also has a business in injectable suspensions. The next step was to seize the opportunities it had in spray drying.
“We invested a lot in people and capabilities and are now number one in amorphous spray drying. No other CMO has all the key elements in lung delivery that we do,” said Villax. “We now offer a complete range of particle design technology all the way through to commercial-scale. We also offer oral and inhalation services to Phase I-II.”
Particle design, according to global sales director Roger Viney, who spoke to SCM separately, “is the link between APIs and formulated drugs. It enables you to change the API’s properties and add value to the formulation, for example in terms of bioavailability, extended release or taste masking. It can add significant value – even a 5% increase in bioavailability can make a huge difference.”
Much of this came about because of the acquisition of a former Pfizer site in Ireland that had exceptional capabilities in this field. However this facility, Villax noted, has only ever made five batches of product, all in campaigns that died in development; the history of this facility, he added, “shows that CMOs are usually much more elegant investors in technology than Big Pharma”.
Whilst solid spray drying is increasingly important, Villax said, it is not the solution to every problem. Hovione is expanding its technology capabilities to address some of the issues of bioavailability, solubility, patient acceptability and so forth that plague drug development. As has been well documented, over half of drugs going through the clinic have solubility issues of some sort.
“We believe our technologies cover 98% of what is usually needed to solve problems. Both at our main site in Portugal and our technology transfer centre in the US, we will have the ability to make APIs, design particles and get them into clinical trials. I believe that we will generally get one or two FDA approvals every year,” Villax concluded.
All this expansion in capabilities did put pressure on the already cramped main site at Loures, Portugal. To accommodate this and create more space for chemistry, Hovione has moved all of its administrative and business functions to a new headquarter within a technology campus in central Lisbon.