In 2016 and beyond, biomanufacturing will be high among the BioWin pole priorities. A sector in which Wallonia has no shortage of qualified players and resources to ensure it is well placed to meet future challenges. In a new flyer we have identified the key Walloon players in this sector, BioWin members that you can discover on our site.

In the same context, we met with one of the principal Walloon players, Novasep Belgium, and interviewed its General Manager, Pierre Lunel, to find out how this fast growing CMO is evolving and how it sees its future in biomanufacturing. The occasion for Mr Lunel to speak with us of the recent partnership with GTP Technology, a move that is allowing Novasep to provide a more comprehensive CDMO offer…

1. Could you just briefly explain the core business of Novasep (formerly Henogen)?

Pierre Lunel: The Novasep Group is organized in three business units: Biopharma, of which  Novasep Belgium is a part,  bio-industry  and organic synthesis. In Biopharma there are two major fields that constitute the heart of the Novasep activities: the CMO (Contract Manufacturing Organization) services and the design and sale of industrial purification equipment. In the field of services, Novasep possesses three production sites, one in France and two in Belgium. Novasep Belgium offers process development, technology transfer and preclinical and clinical production. The Belgian entity has a strong and recognized expertise as for the past 15 years the historical heart of the biopharma activity has been in Belgium, with Henogen. This ULB spin-off was acquired by the Novasep Group in 2009. It is therefore a mature entity in the field of contract production for biopharma.

Since 2013, as part of the global strategy of the “Back to basics” group, we have been refocusing on our principal markets. That is why the Belgian sites at Gosselies and Seneffe have specialised in the production of viral vectors for applications in gene and vaccine therapy. This decision is the consequence of a market demand that requires genuine expertise and specialisation.

The Belgian team has managed a large number of different projects, enabling it to acquire great expertise in the field of viral vector production and gene therapy. A major asset when convincing customers.

2. What makes you stand out from your competitors?

P.L: Our production volume and its quality as our clinical batches are produced under GMP conditions. If we combine our Seneffe and Gosselies sites we are able to produce in bioreactor volumes of between 50 and 1,000 litres in one go. Few other players can match this production capacity. It means we are exceptionally fast and flexible which is exactly what our customers are seeking for their active substance production required for their clinical tests, for example. We can meet the demands of large pharmaceutical companies as well as the Biotechs; we can produce large quantities when necessary, such as to treat haemophilia affecting a large section of the population, but also smaller doses for orphan diseases

We are also developing robust processes, meaning processes with an assured increase in scale. A process developed on a small scale can prove impossible to implement when you move to the industrial scale for clinical phases. Novasep brings its know-how to developing infallible processes, which is a genuine added value for our customers in terms of time and money.

If you would like to find out more about what Novasep does in this field, go to “Novasep Gene Therapy”

3. You speak of two sites in Belgium. How many are there at global level and in what way do they differ the one from the other?

P.L: We have 13 sites in all: six in France, one in Germany, three in Asia (Shanghai, India and Thailand) and two in the US (Boothwyn and Shrewsbury). Each specialises in the production of a particular type of product. At  Gosselies and Seneffe, as I said earlier, we want to concentrate on viral vectors. The difference between the two sites is their production volume. Gosselies has a more modest production, up to 50 litres. Whereas at Seneffe it is from 50 to 1,000 litres. Our French site, at Le Mans, is expert in producing the highly active agents used principally in cancer treatment and in ADCs    (Antibody-Drug Conjugates), while our Pompey site concentrates on mABs and recombinant proteins.   Shanghai focuses on the bio-industry and the supply of turnkey units, so mainly process development and engineering. Each site has its specificities but are also complementary. Together these various sites represent 1,250 jobs, with 150 FTE in Belgium.

4. Last March you joined forces with GTP Technology. What has this partnership brought you?

P.L : We have found that Biotech companies are seeking comprehensive CMDO services that cover all the stages in the development, from the creation of cell lines to the finished product and in different quantities.  Novasep does not propose the development of cell lines so we wanted to acquire the services of a company competent in this field. We had already had the opportunity to work with GTP in the past when it went very well. This French company located in Toulouse (+/- 20 employees) has demonstrated its expertise and ability to find the right line and optimise its production.  When we were looking for a partner, GTP was the obvious choice.

If you would like to find out more about this partnership, please consult the press release or go to  http://www.novasep.com

5. What benefit does Novasep draw from the Walloon ecosystem?

P.L : There are a number of elements at work. Firstly, we are fortunate in that the Walloon environment in the Biopharma sector is such a reservoir of complementary capacity and expertise. At national and international level, this local fabric is a factor of confidence from which we can benefit. In addition, this environment favours meetings and collaboration and that is very enriching for us. Also in terms of human resources, access to a skilled workforce is facilitated. That said, this workforce is much sought after and sometime scarce.   This is the case in the field of viral vectors where Wallonia is certainly not awash with experts. Fortunately training exists through operators such as Cefochim and we can even adapt this to our needs. This also helps make our offer credible.

As far as competition is concerned, this is not so developed in the field of viral vectors in Wallonia. Our principal real competitors are in the US.

What are the ambitions of Novasep Belgium?

P.L : We aim to continue deploying our strategy, in particular by producing commercial batches within the next two years. To this end we are currently upgrading our quality system. Demand is growing sharply and we expect our turnover growth to be every bit as strong as between 2014 and 2015 when we recorded 40% growth!