Five minutes at CPhI North America with

Dr Marco Gil, senior director of commercial services at Hovione

PH: What has been happening at Hovione in the US?

Gil: The expansion at our site in New Jersey is close to completion and will be ready to start manufacturing within a few weeks. This brings us added capacity in API synthesis and in commercial spray drying where there is a growing need in the US; Hovione has a lot of capacity in Europe but did not have any in the US. We see a growing number of projects for poorly soluble compounds with bioavailability challenges, so it is important to have this platform readily available to overcome them, particularly for biotech customers. We have a large pipeline of projects that require this technology and we see this trend continuing more and more in the future. The site in the US will also host a continuous tabletting unit that will come online later in 2018 and which we believe to be a shift in paradigm in the formulation arena.

PH: Was the investment also driven by the general increase in pharma projects in the US?

Gil: Yes, in fact it was mostly done to support a growing number of development projects. It was also important  to be close to our customers in the US, from where most of the innovation in the biotech centre is generated. Things are progressing well. Originally, we built the New Jersey site with a view to taking in early stage projects to transfer into the main site in Portugal but in recent years we have seen increasing interest in supporting late stage development and the launch of new drugs from New Jersey. Besides New Jersey and Portugal, Hovione also has sites in Macau and Ireland providing us a global reach to supply our customers in all regions.

PH: Hovione was probably a CDMO before the term was invented. Is that still an obvious trend in the industry?

Gil: Hovione decided to be an innovative CDMO with a big development arm. We try to be this more and more and we believe this will be even more a trend. There is a growing demand for suppliers that can be true partners in the development of new drugs, with special expertise, niche technologies and not all customers have the internal know-how in all those areas. Biotechs are focused on research and clinical development but not so much on process, manufacturing and CMC. So, in many areas customers are relying on the CDMOs to develop the process and know-how, then be the manufacturer of the product through GMP and then to produce clinical batches and on to commercial. It makes sense: our customers can focus on what they do best and so can we, then they get the best of both worlds. This also provides them access to a lot of expertise that is difficult to access in a single place and gives them a cost-effective and fast way of developing the drug.

PH: Has business been good this year?

Gil: We can’t complain. There has been considerable growth in the CMO business in the last years, we are investing to expand our capacity and establishing partnerships in different technologies. In the next few years, we see the main trends continuing and the good CDMOs with an excellent track record in compliance and with differentiating technologies continuing to be successful. However, we cannot sleep at the wheel and we are looking at what other technologies are out there that can provide solutions to problems. Continuous manufacturing represents a paradigm shift and we are embracing it. We are entering that area through drug product and are also looking at flow chemistry. There are some other interesting technologies being developed and we want to be there, offering new technologies that bring solutions and make them  an industrial reality and available to pharmaceutical companies.

PH: Does the new format of show here work for you?

Gil: For us, this show has been better than the previous format. In general, there are fewer leads coming from being at a show, but we are interacting with a reasonable number of potential and existing customers and we have a good number of meetings booked for the first two days.