Microsaic Systems PLC (LON:MSYS) Chief Executive Officer Glenn Tracey caught up with DirectorsTalk for an exclusive interview to discuss the research agreement with a global biopharma partner, the meaning of a biopharmaceutical, the biologics market and why they are seeing the need for in-process mass spectrometry for biologics that perhaps they wouldn’t see for traditional drugs.
Q1: Microsaic recently announced the signing of a research agreement with a global partner in biopharma, can you tell us a little bit more about that?
A1: Yes, absolutely so I’ve got to say that we are under strict NDA in this particular case but what I can do is give you some context. Earlier in the year we successfully completed a significant joint feasibility phase to show dedicated at-line mass spec can assess the quality of biologics during the manufacture.
I think perhaps the most important aspect of that phase was that we had substantial end-user validation from big pharma and just to say that these are end-users whom our partner has very good global reach. What this new phase is it will bring more end-user validation to the approach, but I think the exciting deliverable is that we’ll be able to provide a lot more technical integration with the partner’s product.
So, should this activity be successful, it will take us into the second half of 2018 and then that will proceed a period of productisation. As I said, I can’t give any details yet about the size and timeline for commercialisation, but the opportunity is significant to us, to Microsaic, and delivery is proportionate, I would say, to our timescales.
Q2: Now, you touched on biopharmaceuticals in your last interview, can you explain to us what is a biopharmaceutical?
A2: Biopharmaceuticals represent one of the most promising frontiers in medicine, they are also known formally as biological medical products or biologics. I think one of the key things that sets them apart from, say, traditional drugs is that they’re produced by genetically-engineered cells such as yeast and bacteria, very much in the same way as a home-brew kit and that sets them apart from traditional chemical synthesis.
Biologics themselves, they’re composed of sugars, proteins, nucleic acids or a combination of substances or increasingly, and in the future, actually living cells and tissues so really quite incredible. They often actually large proteins, they’re very complex but specific structure and that structure is specifically designed to target disease. Their uses range from diseases like psoriasis through to oncology and perhaps the most famous of the latter is the highly-successful treatment for breast cancer, Trastuzumab or Herceptin. That was developed quite a while ago in 1998 by Genentech and UCLA but actually interestingly is now on the World Health Organisation’s list of essential medicines.
I think what really sets them apart, aside from how they’re made, is while there’s extremely good efficacy the biologics specificity also drastically reduces unwanted side effects or adverse drug reactions, ADR’s as we call them. It’s estimated that those cost the US alone in excess of $100 billion annually and I guess it’s a sad case that figure is driven through about 2 million instances of ADR’s per annum in the US and tragically 100,000 deaths. As a matter of fact, the Centre for Education and Research on Therapeutics has put a figure on this as being the fourth largest killer in the US, ahead of pulmonary disease, diabetes, Aids and pneumonia, so it really is quite significant.
Q3: Can you give us a bit more background on the biologics market?
A3: There is a whole wealth of published material out there actually, but I can draw on a recent report that Deloitte estimate that by about the year 2019, biologics revenue in itself is going to earn the pharmaceutical market about $400 billion. That represents about a third of the annual income of the pharma market and I think it’s especially interesting because the term ‘biologic’ was actually relatively unknown even twenty years.
I think to put that into perspective, I can draw on a recent interview with a chap called Andrew Skibo, he’s MedImmune’s Head of Global Biologics Operations and Engineering, he states that across the industry as a whole, there’s around $20 million worth of biopharma site installs either in planning or underway.
Now, if you consider the cost of a new biologics plant can range from anywhere from 1/10 to $0.5 million and take over 5 years to fully implement, you can see that pharma sees an appreciable return on what stands to be obviously a significant level of investment.
For Microsaic Systems, what that means is that obviously the new installs are very interesting to us as a multiple-unit opportunity, actually in both current and future biological installations and this represents our target market.
Q4: Why are you seeing the need for in-process mass spectrometry for biologics that you perhaps weren’t seeing for traditional drugs?
A4: I think that’s the key question and it really is where the true benefit of mass spectroscopy for bioprocessing to be seen and I think it’s quite a detailed response actually.
So, I often compare the two, the biologics and the traditional. If you look at traditional small molecule pharmaceuticals, they’ve got a comparatively simple structure, they’ve also got very well-defined production methods and what it means, in essence, is that these drugs are relatively insensitive to change.
The difficulty we see with biologics goes back to how these drugs are manufactured by cells and the drugs structure or complexity, they’re very large molecules often being 30,000 atoms in size versus 30 for a small traditional drug. The complex structure is very sensitive even for the smallest change in a host of different factors and these can include really anything from manufacturing parameters, differences in raw materials, storage. Even then, when you think you’ve got it defined, unwanted unknowns may introduce problems with the final product or actually with the still very high value intermediary products. Slight changes in structure of the biologic renders them useless or they can actually be potentially lethal and also, any harmful contaminates such as the remnants of the host cell protein can also cause a really nasty and often lethal immune response.
So, it’s really because of these risks that when the FDA grants their biologic licence to a biopharma company, they not only have to consider the product but also the process and the equipment so it’s really much wider than you would consider for a traditional drug. I think in recognition of this task, what the FDA does is to provide guidance of what it calls ‘Quality by Design’ or QbD and that covers four areas and these areas are actually very important for us. It covers four areas, that is the drug’s critical quality attributes to make sure that they meet key physical chemical and biological attributes of the drug itself. The second is that the drug companies identify the critical material attributes the incoming materials, the third is that the manufacturing process conforms to critical process and then that there is a relationship between that whole lot. In other words, basically what the FDA is saying is that things can’t be left to chance.
So, I suppose the punchline here is really what pharma is looking for is very much real-time, powerful analysis that’s needed in many access points across the process, in raw incoming goods, the upstream in sold drug production and downstream purification. All of these areas represent a potential commercial entry point for us, traditional technologies just don’t have the power for that sort of high structural confirmation I was just talking about.
What we’re doing is bringing our powerful detection both at at-line and on-line to provide immediate piece of mind. Just finally, we’re able to do that because we have a very unique all-in-one small footprint, in other words unlike contemporary mass spectrometry, we’ve got no need for cumbersome external pumps and external PC’s and it truly is a point of use mass detector with very easy maintenance and ease of use.
