0:53
But yeah, my name is Mark McDonald.
0:55
I'm one of the senior business development managers with EuroAPI, been in pharma industry for about 20 years and got a background in chemical engineering.
1:05
So I'll just be talking a little bit around EuroAPI as from a broader company perspective about what we can offer.
1:11
And then fortunately, one of my colleagues, Kersten, who's got a lot more experience in the oligos and peptides field, we'll talk through things in a little bit more detail for the rest of the presentation.
1:24
So EuroAPI at a glance.
1:26
So we have about 6 manufacturing sites based in Europe, about 3 1/2 thousand employees or just over headquartered in Paris in France.
1:38
And we as well as our CDMO business, we have around 200 catalogue APIs, so existing molecules that we manufacture as well.
1:49
And although we're based in Europe, we actually have sales and distribution globally, so in more than 80 countries.
1:59
So as the name suggests, we're quite European centric.
2:02
So we have sites covering a number of modalities as well and different technology platforms.
2:07
So not far from here in the UK, so near Cambridge, we have our spray drying centre of excellence that's in Haverhill.
2:15
We have some fermentation sites, so one in Northern France predominantly looking at vitamin B12 manufacturer and one in Southern Italy.
2:24
So manufacturing APIs through fermentation processes in Vertolaye in the centre of France, we have one of our main API or small molecule manufacturing facilities, but they also do corticosteroids, micronisation and some of the solid chemistry activities.
2:42
And then in Budapest we have another large API facility covering you know development programmes, but also some large scale prostaglandin manufacturing.
2:54
And then in Germany, this is where we have our centres for oligonucleotides and peptides.
3:00
So is predominantly in the Frankfurt facility.
3:05
But also recently we acquired a small R&D site in Gera, which used to be BianoGMP.
3:11
So there we do a lot of our R&D oligonucleotide work as well.
3:19
I won't go through everything there, but just to give a bit of a history of some of the sites.
3:24
So although EuroAPI is a new name in the CDMO market, the sites are actually quite long standing and in Frankfurt actually come back over 150 years.
3:35
So a lot of experience in various fields.
3:39
And again, a number of our technical people have been with the company for, you know, 10 plus years or maybe longer.
3:50
So yeah, talked a little bit about our platforms.
3:55
We're structured from a, you know, a platform perspective within R&D, so covering small molecules and high potent APIs as well.
4:03
So we've recently got a new facility online in Budapest covering OEB 5 compounds.
4:09
We have our small molecules and particle engineering functions.
4:12
So this covers micronisation, but also the spray drying facility in the UK, peptides and oligos as we talked about.
4:21
And then also the biotechnology area with the fermentation.
4:26
I think it's important to note as well for each of the sites we can actually go from R&D activities right through to full scale commercials.
4:33
So the teams are very used to onboarding compounds at an early stage and then working with clients to develop that through the clinical phases, always with the mind of a commercial process at the end.
4:49
A couple of bits as well just on our fundamentals, because I think we can all recognise that the science and the technology is great, but without some of the key things underpinning that, we wouldn't be able to make medicines that are available to the market ultimately.
5:03
So, you know, reliability and quality are really key to make sure that we're providing what we need to do at the right time and at the right quality business continuity aspect.
5:14
I think it's important for us, but also for our customers to make sure we're, you know, working together to offer in the right solutions at the right time.
5:22
I think particularly bearing in mind clinical phases and the need to potentially wait for data and respond appropriately to very clinical results.
5:33
And yeah, we pride ourselves on really offering a premium service.
5:36
I think for a lot of our customers being European centric quite helps quite a lot.
5:42
And yeah, with the technical background that's again really something we can offer.
5:51
I think just lastly to touch on the ESG part is really critical for us and you know something that's becoming more and more relevant as we move forward.
6:02
So we won't touch on any everything there, but we were awarded the EcoVadis silver rating two years ago.
6:10
So this is I think the top 3% of companies in the industry for that and it's something we're going back for in 2025.
6:18
And on the solar side, so we're looking to get 100% of our electricity from renewable sources by 2025.
6:29
And actually at the site in the UK, we've recently installed a large 4 MW solar farm.
6:35
So even in the UK we get enough sun to generate electricity for the industrial site.
6:43
So thank you very much.
6:44
I'll just hand you over to Kersten for the rest of the talk.
6:48
Yeah, maybe now a little bit more on science, but unfortunately I can't present any structure.
6:55
Sorry about this.
6:55
This is a customer project.
6:57
Therefore on confidential reasons, I can't present something there.
7:02
But as Mark mentioned, our company as a CDMO is really new.
7:07
We are now a little bit more than two or three years in the business.
7:11
But as also Mark mentioned, we have a lot of people which are employees now for 10, 20, 30 years, but also the company itself based on the company Hoechst AG.
7:26
If you are a little bit older, you know this company, yeah, they started with the peptide synthesis in 76 means a long history.
7:36
We started then in 2003 with oligonucleotide synthesis and 2004 with the peptide synthesis.
7:46
At the moment we do have a commercial product running in A1 kilogramme scale per batch, the Lixi.
7:52
The Lixi is a 44mer and related to a 44mer.
7:57
It's now a biologics means it falls under the BLA.
8:02
We also finished everything to produce Mipomersen which is an oligonucleotide.
8:08
But unfortunately the approval of from the EMA was a problem there for the project died and unfortunately it was not possible to synthesise Mipomersen as a commercial drug.
8:20
But everything was in place at this time.
8:23
For our peptides, typically we use the CS bio platform to do the synthesis.
8:28
We have different synthesiser for different scale as all the other CDMOs too.
8:34
But also we invested now in the Pepti system systems, the Pepti pilot to get an understanding.
8:40
It may be peptide synthesis will be, we'll have more benefit with this kind of synthesiser.
8:48
We work on small projects at the moment and we're very happy with this machine too.
8:53
If you think about commercial scales and that then we are in stainless steel.
9:00
Therefore, this is then the production area.
9:04
We also do the synthesis of oligonucleotides, same as for the peptides here our portfolio based on the Ekta platform up to now, but also here we are looking now for other companies to get an understanding if maybe the machines are also helpful or maybe better.
9:24
Therefore, we bought an AK biosynthesizer, which is now under qualification.
9:29
And yeah, we also are buying an additional oligo process, two millimole machine to produce or it goes in a larger batch.
9:41
Same for the downstream process here.
9:45
We do have different labs here.
9:50
We do have the non-GMP area, the GMP area and the commercial area.
9:56
This is strange.
9:58
It looks like the DSP will not work today.
10:02
Therefore we do have I told you we do have yeah, for all the labs.
10:08
The different, that's strange, different HPLC system with the columns which will fit and the TFE system in place and also freeze drying.
10:26
At the moment, we also ramp up here the downstream equipment.
10:31
Here we invested the last two years €15m to work now in a clean room area with the whole downstream process means the purification can be done now on columns which have diameter of 80 centimetre and also the tank NCR flow filtration will take place in the clean area.
10:55
Room C. This area is now under qualification and we hope that end of this year we can start to purify the first batches for customers.
11:07
Here we also have all the support for the analytical methods in our team, As Mark mentioned, we have also small molecules, peptides, oligonucleotides.
11:24
Therefore, yeah, the people work on all the modalities and everything is in place and yeah, all the methods are established.
11:36
That means we can go from early projects with you up to the market.
11:41
We have the analytical portfolio which is necessary for this means we can develop and validate analytical methods.
11:51
We can run the campaign for you.
11:54
We have a determination of residual solvents and hazard reagents.
11:59
But also as I mentioned before, we have some experience from our pharma business from the past.
12:07
That means here we also yeah able to do some work with you together on authority requests and can move forward with everything here.
12:24
Yeah.
12:24
I think we discussed now three days on peptides and oligonucleotides.
12:30
I think there is really a new area on peptides related to the huge attractivity of some of the peptides, especially the GLP one.
12:41
I think there is now a huge investment also in this field and fortunately I think all other areas which are outside for therapeutics but could also use peptides will also benefit from this investment in the pharma industry.
12:59
And besides the linear and cyclic peptides, I think most of our customer asked for peptide conjugates.
13:09
And here for my understanding, the charming of our company is that we really have experience to produce oligonucleotides, we have experience to use peptides and we have experience in small molecules.
13:23
That means up to now most of our customers which are privileged to work with two or four different companies.
13:32
Yeah, one company produce oligo or small molecule, the other one sent the linker, the I want the peptides and the fourth one maybe do the conjugation.
13:43
In our case we can do everything for you.
13:46
That means most of the people tell it.
13:48
So the one stop shop, I would say all the capabilities in our one location on our side.
13:56
Therefore we have a lot of experience in all the modalities.
14:01
Therefore, we also can combine them for you, and we can start with a research programme and can move forward up to the commercial process with you together.
14:12
But besides our CDMO projects, we also invested in some innovation because we think it's important to have progress to look in new areas.
14:22
And I think we all discussed last three days about green chemistry.
14:28
That means also we are looking in this topics we are looking if we can reduce our removal solvents or reagents.
14:37
We work still on conjugation modalities for the customers to find maybe better linkers or to be more successful for conjugation.
14:47
We also look for example for IPC controls for the peptides with PET means for NMR analysers.
14:54
If we for example could check the coupling time of an amino acid, yeah, that you are sure the that you would not couple the amino acid for six hours and maybe after two hours everything is done.
15:07
And I would check if this is possible.
15:09
For example, we also work on the scalability and the optimization of the synthesis for both for peptides and oligos.
15:17
But also we looked in different purification methods because I think this is really important.
15:23
At the end, the purification will maybe lost a lot of your material if it's not optimal in this case.
15:30
Therefore we looked for some easy clean technologies, which is now partnered with Bachman, but we also looked for example in some flow in some continuous chromatography project together with YMC, Also the active freeze drying process we invested here and the optimization of freeze drying cycles.
15:54
And at the moment we also working to synthesise modified nuclear triphosphates for mRNA synthesis for customers because we thought this could be also still a market and of interest from people.
16:10
Therefore we also invested here.
16:13
Why you should choose us?
16:15
Yeah.
16:16
I think as I mentioned and this is really the charming, I think of our facility that all capabilities are really in one location.
16:24
And we do have the experience here as also we can do work from the laboratory scale up to commercial scale means we have a lot of experience.
16:36
We have strong R&D capabilities also based on our history, we have strong quality system.
16:43
You can think about it, we come from Big Pharma.
16:45
That means everything from big pharma moved to EuroAPI and therefore sometimes, yeah, we are maybe overdone for the quality system.
16:57
All sides are FDA and EMA inspected.
17:00
We still invested in our equipment means for the peptides and also for the oligonucleotides.
17:08
Now we hope that with the qualification of the new purification system, we have the opportunity to purify on this large column we have for each project and management team which work together with you.
17:23
And we up to now we have a very high customer service level up to 90%.
17:29
And yeah, this is all.
17:38
Thank you very much, Kerstin.
17:39
Most interesting.
