Marc Goemans's perspective: The field of contract manufacturing in relation to biologicsFintan Walton:
Hello and welcome to the PharmaTelevision News Review here at AusBiotech, in Melbourne in 2012. On this show I have Marc Goemans, who is Global Vice President of Sales and Marketing at DSM Biologics, welcome.
Fintan Walton:
Mark, you are obviously in the area of biologics for DSM, and of course DSM have a biologics facility here in Australia where we are based, but actually up in Brisbane, So just first of all as somebody who is focused and specialized in the area of biologics how would describe the whole field of contract manufacturing related to biologics at the moment?
Marc Goemans:
I think it's a very exciting field these days, there is a lot of developments going on into the market. Until recently it was mainly developments around new biological entities but in the past few years there is a lot of activity going on in the biosimilars field which brought a different momentum to the market. Second development I would say is the development of single-use technologies. The drive to make the processes more efficient has also made it possible to get into single-use technologies and both of these trends we capture in our units.
Capabilities of DSM Biologics facility in BrisbaneFintan Walton:
Right, okay, and of course just to stress that you are actually based in Holland obviously?
Marc Goemans:
Correct, yes.
Fintan Walton:
Yes, but then just look at the facility here in Australia, because obviously the move of DSM into biologics here in Australia was quite important for both DSM and obviously for Australia, so describe to us what the DSM Biologics facility in Brisbane is, what does it contain and what are your capabilities?
Marc Goemans:
In the grassroot of Princess Alexandra Hospital in Brisbane next to the Translational Research Institute, we have occupied a building of six floors, those are two paired floors, manufacturing floor, one floor is done for manufacturing and the other one is for the utilities. we have had fit only one pair of floors with two 2000 liter bioreactors, and two 500 liter XD or extreme-density process technologies, all in single-use technologies on those floors, and all in all we will start off with a team of about 50 people growing up to 80 depending on how this develops.
Fintan Walton:
Right, so just to be clear about the capabilities, is it purely mammalian or can it do other organisms as well?
Marc Goemans:
It's a very good question, now it's exclusively to mammalian cell culture, is correct.
Fintan Walton:
And embedded in that technology, embedded in that manufacturing technology, how specific, what does DSM bring to the biologic manufacturing that say other companies don't?
Marc Goemans:
I think a standard offering in the industry is a fed-batch technology, I think that's a little bit of the workhorse in terms of the process time, and what we are bringing are processing technologies, the first one is a bioreactor technology called the extreme-density technology which allows you to make a much more efficient and concentrated manufacturing of your process, and in the downstream process we are also bringing new purification technologies, a robust technology which allows you to tremendously cut in terms of processing time and both of these in the end should bring cost benefits to the customer and drive to under cost for the customer.
Fintan Walton:
Right, now one of the things that we know that's happening in the industry, obviously there is a lot of new innovative molecules making their way through, antibodies are clear leader in that field, but also biosimilars, so just in terms of your antibody expression systems, are you capable of doing, are you, have you got a lead in that area?
Marc Goemans:
The question is we, we are a contract manufacturing so we are not doing our own products. We at this stage are doing, the customers bring their cell lines to us, with the opening of our process development capabilities in Brisbane we are also bringing cell line generation to our portfolio and there we will be able to generate cell lines on the various mammalian cell culture platforms. One is CHO XL99, a cell line generated here in Australia by AIBN, another one is PER.C6 that has been running in our portfolio for a while.
Marc Goemans's views: Biosimilars market and DSM's CMO offeringsFintan Walton:
Right, and then just in terms of biosimilars, what sort of impact does, has biosimilars had generally in the market but also from a contract manufacturing point of view, if you are a generics company or even an established pharmaceutical, ethical pharmaceutical company, you may be interested in biosimilars, what is, how would you describe that market and again what can DSM do to facilitate the needs of those companies that want to produce biosimilars?
Marc Goemans:
The biosimilar market is really has developed very rapidly but what do we find in our biosimilars customers is that they are very project driven, so they from start to end they know very well what they need basically because the molecule is already there, so that's one drive, so it's very, very quick, quick transition from Phase I to Phase III. Second of all before the drive of lower cost of goods the players in those markets are very receptive to adopt new technologies. The originated products were based on older platforms and there is a need to drive those cost down, they are looking at the generics in the small molecules, they are parallels with things that will be different there, but so there is also a very large acceptance to try out new technologies and those two bring, yes, come very nicely together in our CMO offering, because we can provide that in our single-use and with our new technologies.
DSM's level of support in clinical developmentFintan Walton:
Of course we often look at manufacturing purely from the when the products on the market, but in terms of clinical development what sort of level of support can DSM give at the very early stages when molecules are at the, at still at the very early stage entering clinical trials and so forth?
Marc Goemans:
You mean for biosimilars or for new biologics?
Fintan Walton:
Well both.
Marc Goemans:
Well I mean the clinical support we can provide, I mean we are doing a pre-clinical all the way to Phase III, so we provide support to all clinical phases. I would say that our facility in Netherlands originally was more laid out for preclinical , Phase I, also there we've had recent expansions that we are able to support commercial. The Brisbane unit is also laid out for preclinical but it's larger in scale, so we expect the Brisbane unit to be able to absorb larger amounts of our commercial needs. First of all by the floor that we are laying out, but second of all also by the empty floor that we have and that is on offer either as a multipurpose unit or as a single product units for any customer who would be interested to partner with us.
Challenges and DSM's support in process development Fintan Walton:
Right, the other component that you've talked about earlier which is the processing end and how important that is, so in terms of the challenges that are, that a company like DSM have to face, in terms of facilitating that for the customer, how much of support can you give to the development of those processes that are required to make that process in the end efficient?
Marc Goemans:
Well the projects that we are running in process development go hand in hand with the customer. The needs are varying, most are very quality driven, and yes we partner up with the customers in getting those technologies to run for our customers. Now we have a very large database of programs that we've run so we will be really able to quickly get the process running on the specs they want, but this is the kind of the support we can provide to our customers, in the end, especially in the biosimilars field, is very much driven to the quantities and the specifications they need.
Fintan Walton:
Okay, yes and then we've talked a lot about mammalian cell systems, what about the microbial side?
Marc Goemans:
Microbial is also a line of business that DSM has in contract manufacturing, but its run from a different business unit in DSM, that business unit is called DSM BioSolutions and that runs its business from in the smaller scale in our research facilities in the Netherlands in Delft, and their commercial skill in the area of Naples, in Italy.
Future capabilities of Brisbane manufacturing facilityFintan Walton:
Okay, and now in terms of just finally then as we look at the development of the Brisbane manufacturing, as we are here in Australia let's look at that, what are the future capabilities of that particular manufacturing facility?
Marc Goemans:
Well for the future what we see is that we start running, initially start running more clinical trial batches, but the unit is completely laid out for commercial skill. So there is one floor right now fitted out with a variety of bioreactors, the other floor we haven't decided yet, all the utilities are there, but we could design it to our way also very quickly because the shell is there so the time to get it running could be very short and but our view is that in the end will be our unit for commercial supply into the market.
Fintan Walton:
Marc Goemans, thank you very much indeed for coming on the show.